Summary
Overview
Work History
Education
Skills
Timeline
Generic

Andrew Saunders

New York,NY

Summary

Goal-driven strategic leader and decisive clinical practitioner with a strong entrepreneurial spirit, open mind, and willingness to take on new challenges that require patience and perseverance.

Logical and perceptive professional with several years of experience leading research focused on studying diseases and other factors to improve human health. Instrumental in conducting clinical investigation assistance, research and development execution in the field. Seasoned and proficient in wide variety of laboratory procedures and data analysis.

Dedicated to clinical research coordination best practices & experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer several years’ experience in the field and take on a fast-faced position.

A clinical research specialist with a high level of expertise in the clinical space across a myriad of therapeutic modalities. With a professional acumen for health intelligence, this demonstrates precision and attention to detail in coordinating, documenting and assisting in clinical trial procedures.

Clear, concise and effective written communication abilities. Thorough knowledge of FDA compliance and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.

Overview

9
9
years of professional experience

Work History

Startup Founder

NeuroMed Research Initiative, LLC.
Washington, District Of Columbia
12.2021 - Current
  • Provided oversight on product development initiatives from concept to completion.
  • Developed business plan to launch startup venture in clinical research, clinical trials, and public health intelligence.
  • Developed business plan to launch startup venture.
  • Established relationships with key stakeholders such as customers, partners, investors.
  • Analyzed industry trends to assess current competitive landscape and identify new opportunities.
  • Negotiated contracts with vendors for resources needed for the startup.
  • Conducted market research and identified target customer segments.
  • Researched emerging technologies that could be leveraged by the startup.
  • Implemented processes to ensure compliance with applicable laws and regulations.
  • Collaborated with external consultants to develop innovative solutions for strategic challenges.
  • Ensured compliance with legal and regulatory requirements relevant to the business operations.
  • Participated in networking events to build relationships with potential partners or customers.
  • Developed case report forms for data collection at investigational sites.
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
  • Reviewed CRFs for completeness and accuracy before database entry.
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Monitored patient safety during clinical trials according to established guidelines.
  • Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
  • Assisted in the preparation of Institutional Review Board submissions for clinical trials.
  • Performed patient assessments, collected and analyzed data, and prepared reports.
  • Developed and maintained accurate and timely study databases.
  • Provided training to study staff on protocol requirements and GCP regulations.
  • Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
  • Coordinated investigator meetings, conference calls, and site initiation visits as needed.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
  • Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
  • Conducted routine visits to research sites to ensure compliance with protocol requirements.
  • Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
  • Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
  • Prepared informed consent forms for review by ethics committees.
  • Collected, processed and delivered specimens from trial participants.
  • Organized, analyzed and modeled study data.
  • 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.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Educated participants on studies and anticipated outcomes.
  • Placed orders for medications to be used in studies.
  • Monitored subject enrollment and tracked dropout details.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Gathered and reviewed study data.
  • Took vital signs and collected medical histories as part of study protocols.
  • Coordinated training sessions for staff regarding Good Clinical Practices guidelines as well as any other required topics related to clinical research operations.
  • Facilitated communication between sponsors, CROs sites and other parties involved in the conduct of clinical trials.
  • Collaborated with sponsors and other stakeholders on the design of clinical trials.
  • Developed and implemented clinical research strategies to ensure compliance with regulatory requirements.
  • Interpreted regulations governing clinical research activities and ensured compliance with applicable laws.
  • Assisted with the preparation of presentations for internal meetings or external conferences and workshops as needed.
  • Actively participated in Data Safety Monitoring Board meetings providing updates on project status as well as any safety concerns that need attention.
  • Generated statistical analysis plans based on protocol requirements using appropriate software programs such as SAS or SPSS.
  • Reviewed ongoing studies for accuracy of documentation while ensuring adherence to GCPs guidelines.
  • Compiled periodic reports detailing project milestones achieved versus planned timelines.
  • Obtained and reviewed data and information from scientific publications and literature.
  • Recommended new systems and processes to improve operations.
  • Identified and recommended improvements in routine analytical methods and processes.
  • Evaluated information and analyzed data to draw conclusions and present findings to scientific community and public.
  • Participated in investigator meetings to discuss trial objectives, data analysis plans and safety monitoring procedures.
  • Conducted literature reviews to identify relevant data sources and analyze results.
  • Prepared protocols, case report forms, informed consent documents and other related materials for submission to ethics committees.
  • Ensured that quality control standards are met throughout all phases of clinical studies by performing regular audits.

Sr. Clinical Research Coordinator

Medix
Baltimore, Maryland
09.2021 - 10.2022
  • Reviewed source documentation for accuracy of data entered into eCRFs.
  • Monitored study progress and documented adverse events in accordance with protocol guidelines.
  • Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
  • Assessed potential sites for suitability as trial participants.
  • Collaborated with internal departments such as Regulatory Affairs, Data Management, and Biostatistics to ensure timely completion of studies.
  • Managed the development of study materials such as questionnaires or training manuals.
  • Prepared financial reconciliation statements for each site involved in the trial.
  • Provided technical support to investigators regarding data entry into electronic case report forms.
  • Developed and maintained regulatory documents for clinical trials.
  • Trained new team members on the principles of Good Clinical Practice and ICH regulations.
  • Evaluated vendor performance related to project deliverables such as supplies or services provided.
  • Facilitated communication between research personnel at multiple sites.
  • Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
  • Created detailed reports summarizing study status, patient recruitment efforts, enrollment trends.
  • Participated in safety review boards to evaluate the safety profile of investigational products.
  • Served as a liaison between sponsors, investigators, vendors throughout the duration of the study.
  • Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
  • Conducted pre-study site visits to assess compliance with protocols and applicable regulations.
  • Assisted with preparation of manuscripts for publication in peer-reviewed journals.
  • Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
  • Organized investigator meetings, prepared agendas, collected presentations, and took minutes at meetings.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Organized, analyzed and modeled study data.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Collected, processed and delivered specimens from trial participants.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Took vital signs and collected medical histories as part of study protocols.
  • Monitored subject enrollment and tracked dropout details.
  • Gathered and reviewed study data.
  • Educated participants on studies and anticipated outcomes.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Placed orders for medications to be used in studies.
  • Clinical Physician Outreach Liaison for Clinical Trial Protocol with Multiple Sclerosis Center of Greater Washington, under clinical supervision of Principal Investigator (PI) & Neurologist, Dr. Heidi Crayton, Washington, DC.

Clinical Research Coordinator

SpringWorks Therapeutics
Stamford, Connecticut
07.2021 - 10.2022
  • Developed case report forms for data collection at investigational sites.
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
  • Reviewed CRFs for completeness and accuracy before database entry.
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Monitored patient safety during clinical trials according to established guidelines.
  • Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
  • Assisted in the preparation of Institutional Review Board submissions for clinical trials.
  • Performed patient assessments, collected and analyzed data, and prepared reports.
  • Developed and maintained accurate and timely study databases.
  • Provided training to study staff on protocol requirements and GCP regulations.
  • Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
  • Coordinated investigator meetings, conference calls, and site initiation visits as needed.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
  • Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
  • Conducted routine visits to research sites to ensure compliance with protocol requirements.
  • Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
  • Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
  • Prepared informed consent forms for review by ethics committees.
  • Collected, processed and delivered specimens from trial participants.
  • Organized, analyzed and modeled study data.
  • 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.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Educated participants on studies and anticipated outcomes.
  • Placed orders for medications to be used in studies.
  • Monitored subject enrollment and tracked dropout details.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Gathered and reviewed study data.
  • Took vital signs and collected medical histories as part of study protocols.

Clinical Research Coordinator

Aerotek Scientific (Actalent)
St Louis, Missouri
11.2020 - 08.2023
  • Developed case report forms for data collection at investigational sites.
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • • Recruited for Double-Blind phase, datamanagement, documented statistical/efficacy analysis plans + diagnostic assessments, administred concomitant therapy, strategized solutions impacted by protocol deviations, monitored AE/SAE datasets for incidental findings. Awarded & Closed Research Contracts: WCG Cinical, WCG ThreeWire, Pfizer Pharmacuticals, SpringWorks Therapeutics, Memorial Sloan Kettering Cancer Center NYC, University of California-San Diego, Medix Life Sciences, & The Multiple Sclerosis Center of Greater Washington, DC.Phase Ill, randomized, double-blinded, placebo controlled trial to evaluate the efficacy & safety of respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy.
  • Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
  • Reviewed CRFs for completeness and accuracy before database entry.
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Monitored patient safety during clinical trials according to established guidelines.
  • Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
  • Assisted in the preparation of Institutional Review Board submissions for clinical trials.
  • Performed patient assessments, collected and analyzed data, and prepared reports.
  • Developed and maintained accurate and timely study databases.
  • Provided training to study staff on protocol requirements and GCP regulations.
  • Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
  • Coordinated investigator meetings, conference calls, and site initiation visits as needed.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
  • Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
  • Conducted routine visits to research sites to ensure compliance with protocol requirements.
  • Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
  • Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
  • Prepared informed consent forms for review by ethics committees.
  • Collected, processed and delivered specimens from trial participants.
  • Organized, analyzed and modeled study data.
  • 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.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Educated participants on studies and anticipated outcomes.
  • Placed orders for medications to be used in studies.
  • Monitored subject enrollment and tracked dropout details.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Gathered and reviewed study data.
  • Took vital signs and collected medical histories as part of study protocols.

Clinical Research Coordinator

ThreeWire
St Louis, Missouri
11.2020 - 08.2022
  • Developed case report forms for data collection at investigational sites.
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • Coordinated with external vendors regarding software updates or system maintenance tasks.
  • Provided technical support to clinical staff during trials as needed.
  • Assisted in the development of study protocols and data collection forms for clinical trials.
  • Monitored patient safety reports submitted by investigators throughout clinical trials.
  • Prepared presentations outlining key findings from completed studies.
  • Documented any changes made to the database structure or content.
  • Collaborated with IT personnel on developing strategies for improving system performance.
  • Developed training materials for new employees related to clinical data management practices.
  • Ensured compliance with applicable regulatory standards including GCP and ICH guidelines.
  • Analyzed results from laboratory tests or imaging scans used in clinical trials.
  • Developed standard operating procedures for data entry processes.
  • Performed quality control checks to verify accuracy of entered information.
  • Identified potential issues related to data accuracy and integrity.
  • Worked closely with statisticians, clinicians, and other team members to ensure proper handling of confidential patient data.
  • Participated in meetings with stakeholders to discuss project timelines and deliverables.
  • Conducted regular audits of database systems to ensure they are functioning correctly.
  • Reviewed source documents for discrepancies between collected data and entered information into database.
  • Assisted with the preparation of statistical analysis plans.
  • Generated reports on research findings, trial progress, and other relevant topics.
  • Managed the transfer of patient data from multiple sources into a single repository.
  • Created, maintained, and updated databases to capture patient information accurately.
  • Developed data management plans and reports, validation procedures and data entry processes.
  • Processed clinical data by entering records of receipt, verification and entry of information.
  • Tailored data management plans to specific projects to effectively reach deadlines.
  • Implemented clinical system requirements, data release formats, delivery schedules and testing protocols to confer with end-users.
  • Adjusted data into necessary formats by using categorization and classification software.
  • Followed standard operating procedures to perform quality control audits.
  • Compiled data to enter necessary information into appropriate databases.
  • Increased productivity and efficiency by regularly reevaluating processes and technologies.
  • Developed procedures for organizing and filing clinical data to enhance workflow efficiency.
  • Analyzed clinical data using statistical tools to identify informational trends.

Clinical Research Coordinator

Pfizer
St Louis, MO
11.2020 - 08.2022
  • Developed case report forms for data collection at investigational sites.
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • Reviewed lab results with physician prior to releasing them to the patient.
  • Responded to messages left on voicemail in a timely manner providing appropriate follow-up instructions when necessary.
  • Answered inquiries from patients regarding treatments, medications and follow-up care instructions.
  • Maintained patient records in electronic health record system and ensured accuracy of data entry.
  • Coordinated referrals between primary care physician offices and specialty service providers as required.
  • Provided administrative support to medical staff by answering phones, responding to emails and filing documents.
  • Maintained confidentiality of all medical records in accordance with HIPAA regulations.
  • Ensured compliance with HIPAA regulations regarding confidentiality of patient information.
  • Managed scheduling conflicts, rescheduled appointments as needed and updated calendars accordingly.
  • Verified patient eligibility for services through various insurances plans including Medicare and Medicaid programs.
  • Prepared charts for upcoming appointments according to established protocols.
  • Greeted patients, verified patient information and scheduled appointments.
  • Communicated effectively with other departments to ensure that all patient needs were met in a timely manner.
  • Assisted physicians during exams by providing requested supplies or equipment.
  • Compiled data from medical records for research projects or surveys conducted by the organization.
  • Maintained confidentiality of records relating to clients' treatment
  • Registered patients and scheduled appointments.
  • Scheduled appointments for patients via phone and in person.
  • Interviewed patients to complete case histories and intake forms.
  • Scheduled and confirmed patient appointments and consultations.
  • Transmitted medical records and other correspondence by mail, e-mail, or fax.
  • Compiled and coded patient information or data in appropriate computer system.
  • Reviewed Informed Consent Forms with patients prior to enrollment into a clinical trial.
  • Coordinated communication between investigators, sponsors, IRBs, and other stakeholders during the duration of the study.
  • Assessed adverse events according to established criteria and reported them promptly to appropriate personnel.
  • Participated in meetings with sponsors or regulatory agencies regarding research studies.
  • Monitored patient progress throughout the course of the trial to assess safety and efficacy of treatment modalities.
  • Evaluated patient medical history and determined eligibility for clinical trial participation.
  • Performed physical examinations, collected specimens, and conducted laboratory tests as required by the study protocol.
  • Ensured compliance with HIPAA regulations when handling confidential patient information.
  • Ensured that all necessary documents are completed accurately prior to initiation of a new study.
  • Provided support services such as scheduling appointments or arranging transportation for participants.
  • Educated healthcare team members about clinical trial procedures and standards.
  • Contributed ideas towards designing innovative approaches for conducting successful clinical trials.
  • Maintained accurate documentation of all research-related activities in accordance with Good Clinical Practice guidelines.
  • Utilized electronic health records systems to track patient information, enter and retrieve data, generate reports.
  • Collaborated with pharmaceutical companies on drug selection for inclusion in a specific trial.
  • Administered treatments according to approved protocols in a safe, accurate, and timely manner.
  • Developed study protocols and collaborated with physicians to ensure accuracy of data collection.
  • Maintained current knowledge of applicable regulations governing human subject protection in clinical trials.
  • Provided patient education on clinical trial procedures and expectations.
  • Prepared reports summarizing results of clinical trials for internal use or external publication.
  • Conducted regular follow-up visits with patients enrolled in clinical trials to monitor their condition and response to treatment regimens.
  • Analyzed, collected and recorded patient health data.
  • Educated patients and family members about preventive health care and recovery.
  • Participated in continuing education programs to maintain clinical competency and stay updated on healthcare advancements.
  • Observed and reported symptoms, reactions and progress of each patient.
  • Initiated discharge planning based on admission assessments.
  • Utilized electronic health record systems to document patient care and outcomes accurately.
  • Offered clinical recommendations to physicians, other healthcare providers or healthcare organizations.
  • Consulted other health care providers in patient discharge, patient care or clinical procedures.
  • Coordinated services between multiple departments to keep procedures and testing on track.
  • Tracked enrollment status of patients in clinical trials.
  • Ensured compliance with FDA regulations and ICH and GCP guidelines for all clinical trials.
  • Responded to queries from internal stakeholders regarding study progress or results.
  • Participated in feasibility assessments for new studies.
  • Prepared reports summarizing study progress from inception through closure.
  • Maintained tracking systems for investigator payments, regulatory documents, and other study related materials.
  • Reviewed and tracked adverse events reported by investigators.
  • Organized meetings with sponsors and investigators regarding protocol amendments or any changes required during the course of a study.
  • Assisted in the preparation of study protocols, case report forms, informed consent forms, investigational product labels, and other related documents.
  • Provided support to Clinical Research Associates on site monitoring activities as needed.
  • Monitored patient safety throughout the duration of a trial.
  • Created and managed clinical trial databases, including data entry of source documents into the database.
  • Developed and maintained trial master files in accordance with GCP and ICH guidelines.
  • Compiled data from multiple sources into a single report format.
  • Performed reconciliation between source documents and database entries to ensure accuracy of information.
  • Collected, processed and delivered specimens from trial participants.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Educated participants on studies and anticipated outcomes.
  • Monitored subject enrollment and tracked dropout details.
  • Gathered and reviewed study data.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Took vital signs and collected medical histories as part of study protocols.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Placed orders for medications to be used in studies.
  • Contractual research for phase Ill, randomized, double-blinded, placebo controlled clinical trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy; Study Protocol under direct clinical supervision of Principal Investigator (PI) and practicing Obstetrics & Gynecology (OB/GYN) Physician, Dr. Kent Branson, MD and Sundance Clinical Research, LLC, Creve Coeur, Missouri.

Clinical Research Coordinator

Memorial Sloan Kettering Cancer Center, Oncology
New York, New York
07.2021 - 10.2022
  • Developed case report forms for data collection at investigational sites.
  • Compiled trial related documents into a master file as required by sponsor or regulatory agency.
  • Reviewed medical records for accuracy of source documentation prior to database lock.

Contractual Research Coordinating & Managing

  • Oncology Data Collection for a Randomized, Double-Blind, Placebo-Controlled, Phase Ill Clinical Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF).
  • Skills: Analytical Reasoning & Problem Solving Skills • Biostatistics • Performance Motivation • Research and Development (R&D) • Oncology Clinical Research • Clinical Operations • General Data Protection
  • Regulation (GDPR) • Neurology • Central Nervous System • Clinical Research Operations • Good Clinical Practice (GCP) • Clinical Research Associates • Global Regulatory Compliance • Clinical Research • Clinical Trial Analysis • Data Analysis • Clinical Site Management • Clinical Trial Management System
  • (CTMS) • Clinical Research Experience • Analytical Skills • Regulatory Analysis
  • Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
  • Reviewed CRFs for completeness and accuracy before database entry.
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Monitored patient safety during clinical trials according to established guidelines.
  • Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
  • Assisted in the preparation of Institutional Review Board submissions for clinical trials.
  • Performed patient assessments, collected and analyzed data, and prepared reports.
  • Developed and maintained accurate and timely study databases.
  • Provided training to study staff on protocol requirements and GCP regulations.
  • Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
  • Coordinated investigator meetings, conference calls, and site initiation visits as needed.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
  • Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
  • Conducted routine visits to research sites to ensure compliance with protocol requirements.
  • Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.
  • Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
  • Prepared informed consent forms for review by ethics committees.
  • Collected, processed and delivered specimens from trial participants.
  • Organized, analyzed and modeled study data.
  • 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.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
  • Educated participants on studies and anticipated outcomes.
  • Placed orders for medications to be used in studies.
  • Monitored subject enrollment and tracked dropout details.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Gathered and reviewed study data.
  • Took vital signs and collected medical histories as part of study protocols.

Science Grant Writer-Team Lead (Internship)

Esurgi Biotech
Baltimore, Maryland
03.2021 - 09.2021
  • Prepared budgets reflecting estimated costs associated with proposed projects or initiatives.
  • Worked collaboratively with internal teams across departments when preparing applications.
  • Oversaw post-award management activities such as tracking expenditures against budget projections.
  • Researched potential funders and wrote tailored grant applications that met the funder's criteria.
  • Reviewed existing policies, procedures, and processes to ensure compliance with grant requirements.
  • Attended meetings or events related to potential or awarded grants.
  • Compiled data from various sources to create comprehensive reports on program activities and outcomes.
  • Managed multiple deadlines while working on multiple projects simultaneously.
  • Identified new sources of grant funding, including corporate, private, and government grants.
  • Monitored changes in regulations related to grant writing activities, making adjustments where necessary.
  • Edited draft proposals prior to submission, ensuring accuracy of all content and adherence to guidelines provided by granting agencies.
  • Provided technical assistance related to the development of project plans or budgeting.
  • Coordinated communications between stakeholders regarding progress toward goals outlined in approved grants.
  • Assembled information from external sources into concise proposal language.
  • Collaborated with staff members to gather information about programs and services for inclusion in the proposal narrative.
  • Responded to proposal questions to make revisions based on donor feedback.
  • Crafted grant requests and proposals for needs.
  • Developed and wrote grant proposals for non-profits, matching needs with available funds.
  • Tracked grant opportunities, deadline dates and required materials.
  • Researched grant opportunities based on funding amount needed, location and organization project.
  • Completed grant applications with supporting documentation to secure funding proposals, grant application narratives and budgets to finalize with development prior to submittal.
  • Science Grant Writer, Team Lead for a Health Biotechnology Firm - Neuroscience & Neuroeconomics DevisionProviding innovative solutions using solid science and common-sense application of technology to improve healthcare delivery.Primary areas of research include: • Alzheimer's Disease, Eye AD (Adjunct Early Screening and Monitoring Tool to Identify Changes Suggestive of Progression of Alzheimer's Disease in Real-Time), Biostabilizer (Pressure Biofeedback Unit), Joint Spy (ACL Injury Research), Le' Mo (Prescription Decision Support Platform for Providers), and Project Rho (Medication Reconciliation Solution)

Graduate Research Assistant

Missouri Institute of Mental Health (MIMH)
St Louis, MO
01.2019 - 04.2020
  • Collaborated with faculty members on grant proposals for external funding sources.
  • Conducted literature reviews and synthesized research findings in preparation for data analysis.
  • Assisted with the design of experiments, study protocols, and data collection methods.
  • Provided administrative support by scheduling meetings, arranging travel plans, taking minutes at meetings.
  • Performed laboratory tests, sample collections, and other technical tasks related to research studies.
  • Participated in weekly lab meetings to discuss ongoing work within the lab group setting.
  • Organized, managed, and maintained databases for research projects.
  • Prepared and presented reports on research progress to faculty members.
  • Interpreted results from experiments or surveys and identified potential implications for further study or applications in practice.
  • Coordinated recruitment efforts for research studies by developing advertisements, screening applicants.
  • Attended professional conferences to present research findings and network with peers in the field.
  • Analyzed qualitative and quantitative data using statistical software packages such as SPSS and SAS.
  • Drafted manuscripts for publication in academic journals based on research findings.
  • Prepared tables, graphs, fact sheets and written reports summarizing research results.
  • Supported principal investigators during research by handling administrative tasks.
  • Gathered, reviewed and summarized literature from scientific journals.
  • Maintained laboratory operations and assisted with testing activities.
  • Identified and resolved data issues to drive accuracy and integrity.
  • Analyzed data to assist professors with various projects.
  • Assisted with execution of data collection, specimen handling and field research.
  • Liaised and collaborated with research teams to pool resources and help answer related research questions.
  • In conjunction with the University of Missouri-St. Louis (Class of 2019, Bachelor of Science- Psychology & Neuroscience) research assistance was under direct supervision of my research mentor, Principal Investigator (PI) Kimberly Werner, PhD
  • The study investigated the biopsychosocial outcomes of trauma survivors of intimate partner domestic violence, including traumatic brain injury (TBI), PTSD, and quality of life in civilian & veteran female populations. Additionally, the team explored substance use outcomes associated with trauma exposure utilizing a psychiatric epidemiology focus to assess substance use, substance use disorder (SUD), and risky behavior in adult patients as a result of childhood trauma.
  • Assisted phase I of a Community Coordinated Response Team (CCRT) Programming Grant funded by the US Department of Justice (DOJ) to address gender-based violence impacting female & LGBTQIA+ students on campus.

Graduate Research Assistant

University of Missouri-St. Louis (UMSL)
St Louis, MO
08.2015 - 12.2019
  • Collaborated with faculty members on grant proposals for external funding sources.
  • Conducted literature reviews and synthesized research findings in preparation for data analysis.
  • Assisted with the design of experiments, study protocols, and data collection methods.
  • Disseminate my own research findings through academic bench work and in the field experience.
  • I presented & published my own work at the institution’s research symposium and other academic conferences.
  • Preliminary data was cross-validated for evaluation, and for credibility, we employed a statistical model using logistic regression analysis to partition the data with parameters to calculate outcome probability using predictive analytics.
  • Methodology revealed a predictive relationship between neurobiological underpinnings of Historical Trauma Response Scores as a Function of Unresolved Grief with or without Substance Use Disorder (SUD) in American Indian (AI) populations (2020) - predicting a distinct binary outcome based on observations.
  • This research was, reviewed, endorsed, and submitted under the direct supervision of research mentor & advisors: Dr. Kimberly Werner, PhD (Assistant Dean of the School of Nursing, Behavioral Neuroscience Faculty) & Dr. Dana Klar, JD., PhD (School of Social Work -Department Chair, Assistant Teaching Professor) at University of Missouri-St. Louis in St. Louis, Missouri.

Education

Master of Science - Strategic Intelligence

Saint Louis University
St Louis, MO
12-2026

Certification, Clinical Research Scholar - Clinical Research & Epidemiology

Harvard Medical School Postgrad Medical Education
Cambridge, MA
08-2023

Master of Science - Research Administration

Johns Hopkins University
Baltimore, MD

Bachelor of Science - Psychology & Neuroscience

University of Missouri-St. Louis
St Louis, MO
12-2019

Skills

  • Marketing expertise
  • Business Networking
  • Industry Expertise
  • Innovation management
  • Strategic Thinking
  • Technical knowledge
  • Data-driven decision-making
  • Trends Analysis
  • Strategic Planning
  • Consulting
  • Contract Management
  • Goal Setting
  • Start-Up Operations
  • Recruitment and hiring
  • Entrepreneurial and Innovative
  • Strategic Vision
  • Legal Compliance
  • Partnership Building
  • Team Engagement
  • Team Leadership
  • Policies and Procedures Development
  • Corporate Governance
  • Dispensing oversight
  • Medication Dispensing
  • Case report management
  • Phlebotomy
  • Documentation requirements
  • Specimen handling
  • Protocol development
  • Trial oversight
  • Research experience
  • Laboratory results management
  • Documentation Management
  • Good clinical practice
  • Report Preparation
  • Schedule Coordination
  • Scheduling proficiency
  • Records Maintenance
  • Site Management
  • Data Analysis
  • Meeting Coordination
  • Database organization
  • Creative Thinking
  • Decision-Making
  • Cross-Functional Team Collaboration
  • Problem-solving abilities
  • Interpersonal Communication
  • Effective Communication
  • Technical Writing
  • Self Motivation
  • Time Management
  • Conflict Mediation
  • Reliability
  • Multitasking
  • Organizational Skills
  • Proposal Development
  • Data Entry
  • Industry trend understanding
  • Active Listening
  • Adaptability and Flexibility
  • Teamwork and Collaboration
  • Analytical Thinking
  • Attention to Detail
  • Due diligence
  • Intelligence collection
  • Research abilities
  • Information Gathering
  • Threat detection
  • Risk Analysis
  • Maintaining records
  • Intelligence Gathering
  • Intelligence Analysis
  • Managing records
  • Information Verification
  • Quantitative Analysis
  • Data Interpretation
  • Data Evaluation
  • Qualitative Analysis
  • Research and analysis
  • Assessing compliance risk
  • Data Collection
  • Report Writing
  • Quality Standards
  • Policy Review
  • Incident Reporting
  • Quality Assurance Controls
  • Standardizing procedures
  • Problem-Solving
  • Problem-solving aptitude
  • Analytical Skills
  • Strategic analysis
  • Data Security
  • Cybersecurity
  • Trend Analysis
  • Information Management
  • Big data technologies
  • Report Development
  • Data Mapping
  • Project Management
  • Stakeholder Communication
  • Regulatory Reporting Requirements
  • Public Information Research
  • Analytical mindset
  • Information assurance
  • Information Security
  • Conduct Standards
  • Teamwork and Loyalty
  • Study design
  • Subject matter expertise
  • Data Management
  • Research management
  • Data Mining
  • Task Prioritization
  • Laboratory safety protocols
  • Administration and management
  • Standards Development
  • Safety Management
  • Critical Thinking
  • Protocol Review
  • Professionalism
  • Records Management
  • Enrollment coordination
  • Disease Research
  • Quality Assurance
  • Study coordination
  • Standard Operating Procedures
  • Regulatory Submissions
  • Subject Screening
  • Training and mentoring
  • Operating EKG Equipment
  • Medical Procedures

Timeline

Startup Founder

NeuroMed Research Initiative, LLC.
12.2021 - Current

Sr. Clinical Research Coordinator

Medix
09.2021 - 10.2022

Clinical Research Coordinator

SpringWorks Therapeutics
07.2021 - 10.2022

Clinical Research Coordinator

Memorial Sloan Kettering Cancer Center, Oncology
07.2021 - 10.2022

Science Grant Writer-Team Lead (Internship)

Esurgi Biotech
03.2021 - 09.2021

Clinical Research Coordinator

Aerotek Scientific (Actalent)
11.2020 - 08.2023

Clinical Research Coordinator

ThreeWire
11.2020 - 08.2022

Clinical Research Coordinator

Pfizer
11.2020 - 08.2022

Graduate Research Assistant

Missouri Institute of Mental Health (MIMH)
01.2019 - 04.2020

Graduate Research Assistant

University of Missouri-St. Louis (UMSL)
08.2015 - 12.2019

Master of Science - Strategic Intelligence

Saint Louis University

Certification, Clinical Research Scholar - Clinical Research & Epidemiology

Harvard Medical School Postgrad Medical Education

Master of Science - Research Administration

Johns Hopkins University

Bachelor of Science - Psychology & Neuroscience

University of Missouri-St. Louis
Andrew Saunders