Oluwayinka Akinyinka
Boston,MA
Summary
Dynamic Clinical Research Coordinator with extensive experience at Brigham and Women’s Hospital, adept at optimizing patient enrollment and ensuring compliance with FDA regulations and GCP guidelines. Proven problem-solver with strong analytical skills, successfully managing multiple clinical trials and mentoring junior staff to enhance team performance and study execution.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical research coordinator 2
Brigham and Women’s hospital
11.2024 - Current
- Ensured procedures were in place for appropriate optimization of patients into the clinical trial.
- Coordinate 8+ industry-sponsored and investigator-initiated clinical trials across oncology, cardiology, and neurology.
- Coordinated multiple sponsor-initiated and investigator-initiated trials.
- Conduct routine inspections of ongoing studies to ensure compliance with study protocols, regulations and ethical criteria throughout the lifecycle of the study.
- Monitored assigned Clinical Trial following company SOP's and in accordance with ICH-GCP.
- Performed risk score calculations (NIHSS, STS, BSA, etc.), protocol-required documentation, and data entry.
- Partners closely with PIs, sponsors, monitors, and IRBs to ensure quality and timely study execution.
- Mentor junior staff and provide study updates in team and department meetings.
- Schedule and document assessments, imaging, labs, and procedures in strict adherence to study timelines and protocols.
- Maintain source documentation and manage re-consent and AE reporting processes.
Clinical Research Coordinator
Velocity Clinical research
01.2021 - 10.2024
- Coordinated the movement of laboratory samples and the resulting data when central laboratory facilities.
- Ensured procedures were in place for appropriate optimization of patients into the clinical trial.
- Monitored assigned Clinical Trial following company SOP's and in accordance with ICH-GCP.
- Perform chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
- Maintain enrollment procedures according to the protocol.
- Conducted day-to-day execution of clinical research protocols including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug compliance.
- Uploaded documents to EDC Rave for multiple studies including critical care studies.
- Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
- Recruited prospective research subjects for clinical trials.
- Responsible for clinical communication with central and local IRBs and maintaining ethical approval for studies, from initial study approval through study amendments, annual continuations, and finally termination.
- Prepared trial related documentation (protocols, Case Report forms, Investigator’s brochure, Consent forms and documents, letters of agreements, confidentiality agreements), organizing IRB submissions with follow-through to ensure successful outcomes.
- Independently obtains informed consent for other clinical studies.
- Mentors Clinical Research Coordinators in training.
- Collect, compile, sort and verify the data’s accuracy or completeness before it is entered.
- Assures that all protocol revisions, informed consent, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.
- Instructs potential study patients, designated caregivers, physicians, nurse clinicians and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments, and side effects.
- Documents study patient's medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.
Clinical Research Coordinator
Pirogov National Hospital 1 - Vinnytsia, Ukraine
Vinnytsia, Ukraine
10.2018 - 11.2020
- Monitored assigned Clinical Trial following company SOP's and in accordance with ICH-GCP.
- Maintains enrollment procedures according to the protocol.
- Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
- Independently obtains informed consent for other clinical studies.
- Uploaded and managed document redactions for studies related to critical care research within ICU unit.
- Reviewed documents related to perioperative surgery studies and trials in early and late phase.
- Prepared trial related documentation (protocols, Case Report forms, Investigator’s brochure, Consent forms and documents, letters of agreements, confidentiality agreements), organizing IRB submissions with follow-through to ensure successful outcomes.
- Performed and assisted in various data entries, management, study design and data analysis.
- Identified quality and performance improvement opportunities and collaborated with staff in the development of action plans to improve quality.
- Confirmed inclusion and exclusion study criteria.
- Instructs potential study patients, designated caregivers, physicians, nurse clinicians and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments, and side effects.
Education
Internal Medicine Residency -
Pirogov National Hospital 1
Vinnytsia, Ukraine01.2020
Doctor of Medicine (MD) - Graduated with Honors
Vinnytsia National Medical University
Vinnytsia, Ukraine01.2016
Skills
- CTMS and eClinical impact
- Microsoft Office Suite
- FDA regulations
- GCP guidelines
- Problem-solving skills
- Clinical research expertise
- Laboratory experience
- Analytical thinking
- Public speaking proficiency
- EDC: Medidata Rave
- Patient care strategies
- Project management
- Team collaboration
- Clinical trials knowledge
- Good clinical practice standards
- Multilingual communication
Certification
- GCP Certification, 01/01/22
- Associate CRA (Onboarding program)
Therapeutic Experience
- Endocrinology: DM Type 1, Hyperthyroidism
- Cardiology: Essential Hypertension, MI
- Neurology/CNS: Chronic Pain, Seizure Disorders
- Gastroenterology: Crohn's, Ulcerative Colitis, GERD, IBS
- Rheumatology: Ankylosing Spondylitis, Sjogren Syndrome, Osteoarthritis, Rheumatoid Arthritis
- Pulmonology: COPD, Bronchitis
- Critical Care: ICU
- Ophthalmology: Glaucoma, Macular Edema
Languages
Russian
Professional
Ukrainian
Limited
References
References available upon request.
Timeline
Clinical research coordinator 2
Brigham and Women’s hospital
11.2024 - Current
Clinical Research Coordinator
Velocity Clinical research
01.2021 - 10.2024
Clinical Research Coordinator
Pirogov National Hospital 1 - Vinnytsia, Ukraine
10.2018 - 11.2020
Internal Medicine Residency -
Pirogov National Hospital 1
Doctor of Medicine (MD) - Graduated with Honors
Vinnytsia National Medical University
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