Mimi Polycarp
Houston,TX
Summary
Knowledgeable Clinical Research Associate adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. Focused Clinical Research Associate well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 8 years of related experience to a challenging new role.
Overview
7
7
years of professional experience
Work History
Clinical Research Associate II
Strata Oncology
07.2020 - Current
- Monitors safety of human subjects and oversees consent procedures to comply with local and federal regulations.
- Conducts pre site selection, site initiation, interim monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Manages clinical monitoring activities to ensure site compliance to the study protocol, Good Clinical Practices (GCPs) and applicable regulations.
- Performs review of clinical data listings for completeness and accuracy and escalate
issues to the Clinical Program Manager as needed. - Proactively and effectively communicates status of clinical studies to management.
- Participates in the interim and final reviews of study data in preparation of regulatory submissions.
- Assists in the review of monitoring trip reports and track resolution of action items.
Clinical Research Associate II
MedPace
02.2019 - 06.2020
- Completed follow up letters for all visit types according to SOPs.
- Participated in monitoring study safety and handling data review and discrepancy resolution.
- 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.
- Ensured IRB approval is obtained prior to study initiation and that IRB requirements are met throughout the duration of the study.
- Ensured proper informed consent are obtained from each study subject prior to participation in the study.
- Suggested subject recruitment strategies in conjunction with the Principal Investigator when required.
- Reported all Adverse Events and Serious Adverse Events within stipulated timelines.
- Adhered to procedures, practices and regulatory requirements to maintain health,
safety and environmental compliance.
Clinical Research Associate I
Covance
03.2018 - 02.2019
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Conducted clinical trial site initiation visits; advised and trained site personnel on sponsor and regulatory requirements for study conduct.
- Monitored study sites and activities to ensure the appropriate industry protocols and terms of the study were being followed.
- Reviewed data queries and listings and worked with study centers to resolve data
discrepancies. - Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggested mechanisms for solving the problem.
- Followed drug storage procedures to comply with protocols and SOP requirements.
Clinical Research Coordinator
UCLA Health
03.2017 - 03.2018
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Prepared, directed, coordinated clinical trial projects.
- Reported Serious/Adverse Events as they occurred and within stipulated timelines.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Administered study questionnaires .
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Followed informed consent processes and maintained records.
Education
Bachelor of Science - Food Sciences And Technology
University of Uyo.
Akwa Ibom State, Nigeria.10.2009
Skills
- Profound knowledge of ICH-GCP and other relevant regulatory requirements
- 5 years of onsite clinical research experience
- Excellent oral and written communication skills in English
- Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools
- Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint
- Experience in phases I-IV clinical trials
- Remote Monitoring Experience
THERAPEUTIC AREAS
• Oncology: Solid Tumor (Adult), Prostrate Cancer, Breast Cancer, Lung Cancer,
Leukemia, Lymphoma and Ovarian Cancer.
• Cardiovascular Disease: Hypertension.
• Neurology: Parkinson Disease, Schizophrenia, Major Depressive Disorder,
Dementia and Huntington Disease.
• Ophthalmology: Glaucoma and Age-Related Macular Degeneration (ARMD).
• Dermatology: Acne and Eczema.
• Infectious Diseases: Flu.
• Medical Device: Cardiac Pacemakers.
• Vaccine: HPV (Human Papillomavirus).
• Rare Disease: Cystic Fibrosis.
Timeline
Clinical Research Associate II
Strata Oncology
07.2020 - Current
Clinical Research Associate II
MedPace
02.2019 - 06.2020
Clinical Research Associate I
Covance
03.2018 - 02.2019
Clinical Research Coordinator
UCLA Health
03.2017 - 03.2018
Bachelor of Science - Food Sciences And Technology
University of Uyo.
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