Summary
Overview
Work History
Education
Skills
Affiliations
References
Certification
Timeline
Generic

Katherine Hewitt

Hayward,USA

Summary

With 25 years of Clinical Research experience ranging from Decentralized Clinical Research, CRO Pharma and Biotech experience, my career has shown that I am a loyal, focused, and driven research professional. My strengths include the ability to communicate and collaborate in a team setting, oversee and integrate CROs and vendors into a project where they are a part of a team, motivating colleagues in a positive manner, multitask, and the ability to use technology to improve the clinical trial process. I can effectively manage multiple projects and contribute to the company objectives simultaneously. I enjoy working in an atmosphere that promotes open communication and encourages thinking creatively. Have created, implemented, and managed Risked Based Monitoring on international, phases I thorough IV, and pivotal trials. Monitored and managed trials in the US, Canada, UK, Ireland, India, France, Latin America, Denmark, Germany, Italy, Spain, Sweden, Netherlands, China, Japan, Russia and Czech Republic in the following therapeutic areas: Oncology Women’s Health, solid tumor, leukemia, multiple myeloma, colon and rectal and Non-Hodgkins Lymphoma (NIH, IITs and Bio/Pharma Sponsored); Osteoarthritis, Pain Management, Crohn’s Disease, Alzheimer’s Disease, Cardiovascular, Endocrinology, Pulmonary, Amyloidosis, Dermatology, many rare diseases and many more. Motivated and methodical Senior Research Associate with extensive track record accomplishing research results to impact planning, innovation, and accountability. Proficient in data capture procedures and action planning. Strong organizational skills and data collection abilities. Demonstrated skills in conducting clinical site visits and resolving issues related to participant eligibility, database protocols, or study procedures. Experience includes various types of clinical trials and studies. Seasoned Senior Clinical Research Associate known for efficient and productive completion of tasks. Specialize in protocol development, patient recruitment strategies, and regulatory compliance management. Excel in communication, problem-solving, and teamwork to drive project success from conception through to completion.

Overview

26
26
years of professional experience
1
1
Certification

Work History

Project Manager, Clinical Operations

Attralus, Inc.
Naples, FL
04.2023 - 07.2025
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.

  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Project Manager, Clinical Operations

ASLAN Pharmaceuticals, Inc.
San Mateo, CA
04.2021 - 04.2023
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.

  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Project Manager, Clinical Operations

PellePharm
San Francisco, CA
04.2018 - 03.2021
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.

  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Sr. Clinical Research Associate

Actellion
South San Francisco, CA
03.2015 - 04.2018
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.

  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Senior Clinical Research Associate

KaloBios, Pharmaceutical Inc.
South San Francisco, California
06.2014 - 02.2015
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.

  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Senior Clinical Research Associate

Rigel Pharmaceuticals, Inc
South San Francisco, California
07.2013 - 06.2014
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.

  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Senior Clinical Research Associate

Janssen Alzheimer Immunotherapy R&D
South San Francisco, California
11.2011 - 07.2013
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Preformed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.
  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Clinical Project Coordinator

IPSEN Pharmaceuticals, Inc.
Brisbane, California
07.2011 - 11.2011
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Preformed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.
  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Clinical Research Regulatory Coordinator

Nevada Cancer Institute
Las Vegas, NV
09.2010 - 03.2011
  • Coordinated regulatory submissions to ensure compliance with industry standards.
  • Reviewed clinical trial protocols for adherence to regulatory requirements.
  • Maintained documentation for regulatory audits and inspections efficiently.
  • Collaborated with research teams to prepare regulatory reports accurately.
  • Monitored changes in regulations to update internal processes promptly.
  • Liaised with external regulatory agencies on compliance matters consistently.
  • Communicated regularly with external stakeholders regarding status updates on submissions.
  • Maintained up-to-date records of product registrations, renewals, and notifications.
  • Prepared documents for submission to relevant authorities as needed.
  • Provided support on regulatory issues related to product development, quality assurance, and safety standards.
  • Monitored changes in regulations impacting existing products or processes.
  • Tracked progress of submissions throughout their life cycle.
  • Ensured timely submission of documents required by health authorities for registration applications.
  • Facilitated communication between internal teams regarding regulatory matters.
  • Managed upkeep of regulatory electronic and hard copy filing systems and archives.
  • Evaluated changes to documents submitted to determine need for amendments.
  • Updated in-depth trackers of approvals and submissions.
  • Submitted applications and amendments to regulatory agencies.
  • Enforced regulatory affairs department compliance with agency requirements.
  • Liaised with contacts such as pharmaceutical companies.
  • Investigated product complaints and prepared documentation and submissions to appropriate regulatory agencies.
  • Collaborated across internal departments to achieve regulatory objectives and maintain compliance of products.

Sr. Clinical Research Coordiantor

Benvenue Medical
Santa Clara, California
03.2010 - 08.2010
  • Coordinated clinical trials in compliance with regulatory standards and protocols.
  • Managed patient recruitment and retention strategies for ongoing studies.
  • Collaborated with multidisciplinary teams to ensure effective trial execution.
  • Oversaw data collection processes to maintain accuracy and integrity.
  • Conducted site visits to monitor compliance and assess trial progress.

  • Ensured timely reporting of adverse events following company guidelines and regulations.
  • Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
  • Provided technical support to investigators regarding data entry into electronic case report forms.
  • Created detailed reports summarizing study status, patient recruitment efforts, enrollment trends.
  • Collaborated with internal departments such as Regulatory Affairs, Data Management, and Biostatistics to ensure timely completion of studies.
  • Monitored study progress and documented adverse events in accordance with protocol guidelines.
  • Managed the development of study materials such as questionnaires or training manuals.
  • Reviewed source documentation for accuracy of data entered into eCRFs.
  • Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
  • Developed and maintained regulatory documents for clinical trials.
  • Prepared financial reconciliation statements for each site involved in the trial.
  • Organized, analyzed and modeled study data.
  • Gathered and reviewed study data.

Senior Clinical Research Associate

ICON Clinical Research Organization
Redwood Shores, California
10.1999 - 08.2009
  • Coordinated documentation for clinical trial protocols and regulatory submissions.
  • Supported team in scheduling meetings and organizing trial-related events.
  • Reviewed reports for adherence to regulatory guidelines and internal standards.
  • Collaborated with clinical research teams to streamline workflow processes.
  • Prepared submissions for Institutional Review Board or Ethics Committee approval, amendments, renewals.
  • Ensured timely completion of essential documents by investigators and research staff.
  • Tracked subject enrollment status, screening results, adverse events, concomitant medications.
  • Maintained regulatory documents such as informed consent forms and investigator brochures.
  • Supported administrative staff by processing payments.
  • Coordinated project timelines and schedules for multiple initiatives.
  • Facilitated communication between stakeholders and project teams.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Developed and maintained project plans, timelines, and budgets.
  • Built and established strong partnerships with teams, vendors and contractors.
  • Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
  • Maintained records of all documents related to each project including specifications, change orders, invoices.
  • Led meetings with internal team members, consultants and contractors.
  • Conducted periodic inspections of job sites for quality and progress.
  • Identified risks associated with each project and developed strategies for mitigating those risks.
  • Managed contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.
  • Ensured compliance with applicable laws, regulations, policies and procedures throughout the life cycle of each project.
  • Generated and tracked change orders and other contractual modifications affecting budget and schedule.
  • Drafted reports summarizing progress made on projects for review by executive leadership team.
  • Monitored project progress and reported updates to management.
  • Developed project plans outlining deliverables and milestones.
  • Managed resource allocation to ensure project efficiency.
  • Conducted risk assessments to identify potential project challenges.
  • Assisted in budget management for ongoing projects.
  • Managed site selection and initiation for clinical trials across diverse therapeutic areas.
  • Coordinated monitoring visits to ensure compliance with study protocols and regulations.
  • Reviewed and validated clinical data for accuracy and completeness during trial phases.
  • Collaborated with cross-functional teams to address site-related issues promptly.
  • Assisted in developing study-specific materials to support investigator sites effectively.
  • Evaluated vendor performance to ensure quality standards met throughout the trial lifecycle.
  • Maintained regulatory documents, ensuring readiness for audits and inspections consistently.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Preformed pre-study, closeout and interim visits to check on study activities.
  • Checked electronic data capturing systems for integrity and compliance.
  • Tracked study-specific trial management tools and systems.
  • Identified potential threats to properly manage project risks.
  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Collaborated with project teams to contribute research methods for trials.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Communicated research and analytical findings to research team.
  • Coordinated shipment of investigational product samples to sites.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Identified potential investigators, sites that met inclusion, exclusion criteria for studies.
  • Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
  • Prepared reports summarizing findings from monitoring visits.
  • Negotiated investigator budgets for site contracts with support from department.
  • Assisted in the development of informed consent documents according to local regulations.
  • Reviewed laboratory results for accuracy prior to database lock.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Conducted periodic conference calls with investigative sites.
  • Reviewed protocols, case report forms and other study documents for accuracy.
  • Provided support to internal audit teams conducting audits at investigative sites.
  • Collaborated with vendors on developing project timelines, budgets, and milestones.
  • Ensured timely submission of required documents from investigative sites.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Organized, analyzed and modeled study data.

  • Assisted with preparation for FDA inspections as needed.
  • Conducted independent research to assimilate results for technical reports and publications.
  • Managed study site with strict adherence to data security measures.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Delegated tasks to teams developing project schedules, resource requirements and timelines.

Education

Some College (No Degree) - Project Management

University of Phoenix
Phoenix, AZ

Skills

  • Site management in clinical trials
  • Startup and monitoring processes
  • Visit scheduling and coordination
  • Documentation review and collection
  • Negotiation of contracts and budgets
  • Vendor assessment and selection
  • Training program development
  • Timeline creation and oversight
  • Management of trial phases I-IV
  • Standard Operating Procedures development
  • Data analysis techniques
  • Microsoft 365 applications mastery
  • Google programs utilization
  • Trello project management
  • Zoom meeting facilitation
  • Adobe Acrobat proficiency
  • Florence software application
  • Veeva Vault system expertise

Affiliations

SOCRA, 01/01/24, ongoing

References

Available upon request

Certification

  • CITI ICH-GCP Training (exp. November 2025)
  • CCRC Certification (pending certificate, exam completed Aug. 2025)

Timeline

Project Manager, Clinical Operations

Attralus, Inc.
04.2023 - 07.2025

Project Manager, Clinical Operations

ASLAN Pharmaceuticals, Inc.
04.2021 - 04.2023

Project Manager, Clinical Operations

PellePharm
04.2018 - 03.2021

Sr. Clinical Research Associate

Actellion
03.2015 - 04.2018

Senior Clinical Research Associate

KaloBios, Pharmaceutical Inc.
06.2014 - 02.2015

Senior Clinical Research Associate

Rigel Pharmaceuticals, Inc
07.2013 - 06.2014

Senior Clinical Research Associate

Janssen Alzheimer Immunotherapy R&D
11.2011 - 07.2013

Clinical Project Coordinator

IPSEN Pharmaceuticals, Inc.
07.2011 - 11.2011

Clinical Research Regulatory Coordinator

Nevada Cancer Institute
09.2010 - 03.2011

Sr. Clinical Research Coordiantor

Benvenue Medical
03.2010 - 08.2010

Senior Clinical Research Associate

ICON Clinical Research Organization
10.1999 - 08.2009

Some College (No Degree) - Project Management

University of Phoenix

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Katherine Hewitt