Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Affiliations
Clinical Research Experience
Computer Experience
Timeline
BusinessDevelopmentManager

Tanya Fox

Portland,USA

Summary

To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy while being mindful of regulatory implications. Knowledgeable Clinical Trial Manager adept at recognizing clinical limitations and advantages of decision making for the study and team members.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Clinical Trial Manager/Sr. Clinical Trial Manager

Biorasi, Inc
08.2021 - Current
  • Manages all clinical aspects of study either regionally or globally, depending on assignment
  • Includes assessing operational feasibility; managing Clinical study timelines and metrics; provides study-specific training and leadership to clinical team; prepares and presents project debriefings, as required; plan, execute, lead study-specific meetings (e.g., Study Management Meetings, investigator meetings)
  • Responsible for ensuring that Clinical Team delivers timely and high-quality project deliverables
  • Uses operational and therapeutic expertise to optimize trial execution
  • Determine or contribute to list of approved sites for selection visits.
  • Plan allocation of clinical team resources
  • Determine, develop, and implement tracking and reporting specifications
  • Prepares study-related documents to include, visit report templates and annotations, clinical logs, forms, manuals, and guidelines.
  • Oversee collection, review and filing of site essential documents, and maintenance of TMF.
  • Facilitates IP/ID release and site activation process based on scope of project.
  • Proactively works with CRA’s to meet start-up, SIV and site activation timelines.
  • Track and manage subject recruitment at all study sites.
  • Oversees study management of Monitoring Visits, and review and approval of Monitoring Reports
  • Monitor study/site performance consistently and escalate any infringements, breaches, and misconduct, fraud, and trends at sites.
  • Ongoing protocol deviation tracking, reporting, and trending
  • Notify internal and external global study information and updates.
  • Monthly reporting of identified quality metrics to Quality Assurance and executive management.
  • Coordination of IP and clinical study supplies and oversee overall tracking of clinical supplies at all sites in coordination with established systems such as IWRS, EDC, CTMS, or vendor-specific systems.
  • Manage study vendors as it relates to clinical activities, timeline, and scope of work.
  • Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies
  • Participates in planning of quality assurance activities whether for cause or random selection
  • Coordinates resolution of audit findings and CAPA’s through their completion cycle
  • Serve as functional Manager to Clinical Operations staff allocated, as well as aspects of functional management with clinical study team members on assigned projects
  • Provides coaching and guidance to junior and senior Clinical staff.
  • Develops relationships with investigators and site staff.
  • Frequent cross-functional interactions with internal and external team personnel (e.g., regulatory affairs, investigators, vendors, etc.)
  • Lead regular team meeting/teleconferences; Participate/present at Client Presentation Meetings; Participate/present at Investigator Meetings
  • Communicate any out-of-scope issues to Senior Clinical Management Team or Project Management Team as soon as identified.
  • Participate in Bid Defense preparation meetings as well as Bid Defenses; present during Bid defenses as it relates to Clinical aspects of study.
  • Companywide training presentations: How to Identify Issues/Trends while completing Monthly Quality Metrics Review of Essential Documents
  • Clinical budget review for accurate usage; oversee clinical portion of budget and track status, appropriate usage, and identify inappropriate usage of clinical study budget.
  • Conducted Monitoring Evaluation Visits, routine, and for-cause.
  • Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
  • Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
  • Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
  • Championed continuous improvement initiatives within organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
  • Implemented risk management strategies, effectively minimizing potential threats to success of clinical trials.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
  • Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
  • Complied with research protocols by providing ongoing quality control audits.
  • Spearheaded selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Developed training materials for site staff to enhance their understanding of study protocol, resulting in improved adherence to requirements.
  • Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
  • Evaluated vendor performance regularly to ensure high-quality services were provided throughout duration of clinical trial.
  • Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
  • Mitigated risks in clinical trial process by proactively identifying potential issues and implementing corrective actions.
  • Worked effectively in fast-paced environments.
  • Organized and detail-oriented with strong work ethic.
  • Demonstrated leadership skills in managing projects from concept to completion.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Identified issues, analyzed information and provided solutions to problems.
  • Proven ability to learn quickly and adapt to new situations.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Self-motivated, with strong sense of personal responsibility.
  • Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.

Senior Clinical Research Associate

Covance/LabCorp
04.2017 - 08.2021
  • Previously responsible for all aspects of study site monitoring that included routine monitoring and close-out of clinical sites, maintenance of study files, conduction of pre-study and initiation visits; consulting with vendors; and other duties, as assigned
  • Ensured study staff who were to conduct protocol had received proper materials and instructions to safely enter patients into study.
  • Ensured protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to applicable regulatory requirements.
  • Ensured integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and verification.
  • Monitored data for missing or implausible data.
  • Ensured company and sponsor resources were utilized wisely.
  • Ensured audit readiness at site level.
  • Prepared accurate and timely trip reports.
  • Managed small projects under direction of Project Manager/Director as assigned.
  • Served as lead monitor for protocol or project and assisted in establishing monitoring plans and trip report review as assigned.
  • Reviewed progress of projects and initiated appropriate actions to achieve target objectives.
  • Participated in writing clinical trial reports as assigned.
  • Interacted with internal work groups to evaluate needs, resources, and timelines.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Contributed to development of informed consent forms, and case report forms to ensure consistency across clinical trials.

Lead Site Monitor I Senior Clinical Research Associate

PRA International
09.2013 - 05.2016
  • Previously responsible for overall adherence and productivity of all assigned clinical protocols at site level.
  • Conducted site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits and site close out visits.
  • Communicated site study issues, concerns and progress to Clinical Project Manager, Regional Monitoring Manager and Clinical Operations Manager accordingly.
  • Wrote study visit reports and follow-up letters within timeline established by applicable SOPs and guidelines.
  • Collaborated with Clinical Project Manager, Regional Manager and/or Clinical Operations Manager/study teams to resolve site issues.
  • Reviewed study visit reports, follow-up letters and site communication generated by other Clinical Research Associates for timeliness, quality, consistency and appropriate documentation and resolution of issues.
  • Kept detailed records of all site activities for accurate reporting, analysis, and decision-making purposes.
  • Fostered strong teamwork among staff members which contributed positively towards overall job satisfaction levels at worksite.
  • Increased overall site efficiency by implementing organized systems for daily operations and task management.
  • Reduced downtime on projects by troubleshooting issues quickly and efficiently, resulting in faster completion times.
  • Contributed to successful project outcomes by adhering to established budgets and ensuring cost-effective solutions were implemented where possible.
  • Streamlined project timelines through effective communication with team members and proactive problem solving.
  • Evaluated project progress regularly against established goals to make adjustments as required for optimal results.
  • Demonstrated adaptability by effectively responding to unexpected challenges or changes in project scope, ensuring minimal disruption to schedules and deliverables.
  • Ensured compliance with company policies and industry regulations by continually reviewing and updating documentation.
  • Managed risks effectively through early identification strategies; taking appropriate action to minimize impacts on project timelines or budget constraints.
  • Worked effectively in fast-paced environments.
  • Skilled at working independently and collaboratively in team environment.
  • Organized and detail-oriented with strong work ethic.
  • Excellent communication skills, both verbal and written.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations..
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Proven ability to learn quickly and adapt to new situations.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout study duration.
  • Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
  • Assisted in budget planning and forecasting for clinical research projects, optimizing resource allocation while maintaining high-quality standards.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Resolved problems, improved operations and provided exceptional service.
  • Demonstrated creativity and resourcefulness through development of innovative solution.
  • Developed and maintained courteous and effective working relationships..
  • Self-motivated, with strong sense of personal responsibility.
  • Demonstrated high level of initiative and creativity while tackling difficult tasks.
  • Identified issues, analyzed information and provided solutions to problems.

Senior Clinical Research Associate (Oncology)

Theorem Clinical Research
01.2012 - 12.2012
  • Identified potential investigational sites; coordinated and performed comprehensive site management.
  • Conducted pre-study, initiation, interim and close out monitoring visits; produced comprehensive visit reports and status reports
  • Resolved data issues and audit issues; adhered to study timelines and budget.
  • Mentored less experienced Clinical Research Associates; collected high quality essential documents.
  • Completed all other assignments given assigned by management or as business needs required.
  • Followed informed consent processes and maintained records.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout study duration.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
  • Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Applied effective time management techniques to meet tight deadlines.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Skilled at working independently and collaboratively in team environment.
  • Proved successful working within tight deadlines and fast-paced environment.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Developed and maintained courteous and effective working relationships.
  • Paid attention to detail while completing assignments.
  • Demonstrated high level of initiative and creativity while tackling difficult tasks.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.

Clinical Research Consultant

Advanced Clinical, Inc.
01.2011 - 01.2012
  • Conducted client and assignment specific-based consulting.
  • Contracted employee as Senior Clinical Research Associate.
  • Evaluated potential new sites for future studies, considering factors such as patient population demographics, available resources, and local regulatory requirements.
  • Delivered high-quality training materials to site staff, improving their understanding of study procedures and requirements.
  • Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
  • Proven ability to learn quickly and adapt to new situations.
  • Identified issues, analyzed information and provided solutions to problems.
  • Worked effectively in fast-paced environments.
  • Organized and detail-oriented with strong work ethic.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Skilled at working independently and collaboratively in team environment.
  • Excellent communication skills, both verbal and written.
  • Proved successful working within tight deadlines and fast-paced environment.


Senior Clinical Research Associate, Oncology

INC Research
12.2010 - 06.2011
  • Previously responsible for monitoring all phases of clinical trials.
  • Assured adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures.
  • Assisted with preparation and attended investigator's meetings as requested; may present as requested.
  • Assisted with the preparation of study start up materials and tools, as requested
  • Attended clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions per the project communication, monitoring and/or training plans
  • Composed sponsor site audit responses.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
  • Learned and adapted quickly to new technology and software applications.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Demonstrated creativity and resourcefulness through the development of innovative solutions.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Passionate about learning and committed to continual improvement.
  • Paid attention to detail while completing assignments.
  • Worked well in a team setting, providing support and guidance.
  • Proven ability to learn quickly and adapt to new situations.

Senior Clinical Research Associate

Quintiles
08.2008 - 12.2010
  • Provided monitoring visits and site management for variety of protocols that were complex and/or require knowledge in advanced therapeutic areas.
  • Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluated quality and integrity of study site practices related to proper conduct of protocol and adherence to applicable regulations.
  • Created and presented staff education program on HIV pathophysiology and clinical manifestations of disease.
  • Recruited subjects for participation in research project.
  • Consented subjects for participation in research project.

Clinical Research Associate I and II

PPD
07.2006 - 08.2008
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Identified areas for process improvement within clinical trials, implementing changes to enhance overall project efficiency and quality.
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Supported successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of study process.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
  • Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
  • Managed multiple projects simultaneously while maintaining high level of attention to detail and meeting deadlines.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Proved successful working within tight deadlines and fast-paced environment.
  • Excellent communication skills, both verbal and written.
  • Passionate about learning and committed to continual improvement.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Organized and detail-oriented with a strong work ethic.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Paid attention to detail while completing assignments.

Clinical Research Coordinator

Oregon Health Sciences University
06.2004 - 07.2006
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.


  • Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
  • Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
  • Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Streamlined data collection processes for increased efficiency and accuracy in study results.
  • Trained new team members on essential clinical research protocols and procedures, promoting culture of continuous learning.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Improved recruitment rates by developing and implementing effective patient outreach strategies.
  • Reduced data entry errors by implementing stringent quality control measures throughout study lifecycle.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Followed informed consent processes and maintained records.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Gathered, processed, and shipped lab specimens.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Resolved problems, improved operations and provided exceptional service.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Organized and detail-oriented with strong work ethic.
  • Skilled at working independently and collaboratively in team environment.
  • Worked effectively in fast-paced environments.
  • Identified issues, analyzed information and provided solutions to problems.
  • Gained strong leadership skills by managing projects from start to finish.
  • Learned and adapted quickly to new technology and software applications.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Paid attention to detail while completing assignments.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Proved successful working within tight deadlines and fast-paced environment.

Education

No Degree - Clinical Research Administration

George Washington University
Online
09.2006

Bachelor of Science - Health Sciences And Biology

Linfield University (formerly Linfield College)
Portland, OR
06.1997

Skills

  • Oncology Clinical trial expertise
  • Trial Management/Clinical Trial Oversight
  • Line Management
  • Extensive ICH/GCP Knowledge
  • GDPR Knowledge
  • Adverse event reporting
  • Records Management
  • Investigator Relations
  • Quality Assurance
  • Informed consent writing and review
  • Regulatory Submissions
  • Audit preparation
  • Stakeholder Communication
  • Protocol Review
  • Results-Oriented
  • Site monitoring
  • Training and mentoring
  • Standard Operating Procedures
  • Site Selection
  • Document Review
  • Teamwork and Collaboration
  • Problem-Solving
  • Critical Thinking
  • Recordkeeping
  • Task Prioritization
  • Analytical and Critical Thinking
  • Customer Service
  • Self-Directed
  • Remote Office Availability
  • Friendly, Positive Attitude
  • Computer Skills
  • Microsoft Office
  • Networking
  • Analytical Thinking

Accomplishments

    Biorasi Clinical Trial Manager of the Year 2022

    Sigma 6 Lean Black Belt Candidate 2023-current

Certification

Certified Clinical Research Professional

Affiliations

Society of Clinical Research Associates

Clinical Research Experience

  • Oncology: Solid Tumors – Head and Neck (SSC) Lung Cancer (Non-Small Cell Lung Cancer) (Phase I)
  • Hematologic Malignancies - Leukemia (Phase I, II), Hodgkin's or Non-Hodgkin's Lymphoma (Phase I, II), Myelodysplasia (Phase I, II), Multiple Myeloma (Phase I, II), Cancer Supportive Care - Cancer pain (Phase II)
  • Immunotherapy- Multiple Myeloma (phase I, FIH), AML (phase 1, FIH)
  • Hematology - Coagulation disorder (Phase II, Ill)
  • Oncology Specific Grading Systems: RECIST 1.1, iRECIST 1.1, TNM Classification, CTCAE
  • Cardiometabolic: Cardiovascular Disease- Heart Failure (Phase II), LV dysfunction (Phase II), Dysrhythmia (Phase II. Ill), Atrial fibrillation (Phase II), Venous Thrombosis (Phase II), VTE/DVT, PE (Phase II, Ill)
  • Neuroscience: General Neurology: Alzheimer's (Phase II, Ill), Multiple Sclerosis (Phase II)
  • Infectious Disease: Multiple Drug Resistant Bacterial Infection (Phase II), Fungus and Parasitic Disease Therapy (Phase II)- Candidiasis, Cryptococcosis, Aspergillosis, Coccidioidomycosis, Histoplasmosis, and (multiple) drug resistant infections, Anti-Viral Therapy - HIV/AIDS (Phase II), Influenza, CMV, HPV (Phase II, Ill), Ebola (phase I), - Bacterial or Viral Disease Prevention (Phase II, Ill)
  • Pediatrics: Type II Diabetes (Phase Ill)
  • Device: Diagnostic procedure/device evaluation (Phase Ill), Photoimmunotherapy Squamous cell carcinoma of the head and neck
  • Immune Mediated Inflammatory Disease (IMID): Allergy - Allergy Vaccines (Phase Ill)
  • Ophthalmology: Device
  • Dermatology: Rosacea

Computer Experience

  • CTMS
  • Microsoft Office Suite
  • Power BI
  • Medidata
  • Inform
  • Zelta (formerly IBM Clinical)
  • Suvoda
  • Almac
  • Imaging Endpoints
  • Veeva Vault
  • Cobblestone
  • Kronos
  • FLORENCE
  • IRB Portals (Advarra and WCG)
  • EMR
  • Open Air

Timeline

Clinical Trial Manager/Sr. Clinical Trial Manager

Biorasi, Inc
08.2021 - Current

Senior Clinical Research Associate

Covance/LabCorp
04.2017 - 08.2021

Lead Site Monitor I Senior Clinical Research Associate

PRA International
09.2013 - 05.2016

Senior Clinical Research Associate (Oncology)

Theorem Clinical Research
01.2012 - 12.2012

Clinical Research Consultant

Advanced Clinical, Inc.
01.2011 - 01.2012

Senior Clinical Research Associate, Oncology

INC Research
12.2010 - 06.2011

Senior Clinical Research Associate

Quintiles
08.2008 - 12.2010

Clinical Research Associate I and II

PPD
07.2006 - 08.2008

Clinical Research Coordinator

Oregon Health Sciences University
06.2004 - 07.2006

No Degree - Clinical Research Administration

George Washington University

Bachelor of Science - Health Sciences And Biology

Linfield University (formerly Linfield College)

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Tanya Fox