Fareedat Omijori
SCRA
Laurel,MD
Summary
Supported management of clinical trials across various therapeutic areas for 7 years.,Assisted in fostering strong site relationships and maintaining regulatory compliance.,Aided in mentoring junior staff and contributing to team success.
Overview
1
1
Certification
9
9
years of professional experience
Work History
Hospital Corpsman Third Class
United States Navy Reserve
07.2025 - Current
- • Ensure compliance with training requirements, operational procedures, and organizational standards• Provide medical, administrative, and operational support within military healthcare environments.• Maintain accurate personnel and medical documentation while ensuring compliance with military regulations and confidentiality requirements.• Support readiness programs, safety initiatives, and emergency preparedness activities.• Collaborate effectively within multidisciplinary teams in fast paced and high pressure environments.• Demonstrate leadership, adaptability, accountability, and strong communication skills.
- Provided patient care and support in diverse clinical settings.
- Assisted medical personnel with examinations and procedures to enhance patient outcomes.
- Administered medications and monitored vital signs to ensure compliance with treatment protocols.
- Trained junior corpsmen on medical procedures, safety protocols, and equipment usage.
Senior Clinical Research Associate
Merck
08.2023 - Current
- Conduct site qualification, initiation, monitoring and close-out visits, submit timely reports, and assist with site selection.
- Serves as the main contact for assigned study sites.
- Ensure adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements.
- Review source documentation, case report forms and data reports for accuracy, completeness, and timely submission.
- Manage investigational product accountability.
- Communicate and work with site investigators and research staff to ensure proper reporting of adverse events and protocol deviations and escalate critical compliance issues to manager promptly.
- Collect and transfer required site documents to the trial master file.
- Provide site updates at study meetings.
- Participate in the development of study documents (protocols, monitoring plans, case report forms, informed consent forms, study manuals) and EDC user acceptance testing.
- Mentor and train CRAs in accordance with company procedures and ensure consistency with study practices, training, proctoring across CRA team members and clinical sites.
- Review monitoring reports, trend compliance issues, create solutions and escalate to manager, as required.
- May facilitate review meetings for study updates, adverse events, and protocol deviations
- Assist with routine quality audits to ensure that clinical sites maintain necessary study documentation and adhere to protocol requirements.
- Attend relevant scientific meetings as directed.
Clinical Research Associate I/II
Syneos Health
06.2019 - 08.2023
- Developed and illustrated understanding and adapting expertise in the therapeutic area to assignments and project-related problems.
- Provided site control and tracking assistance for sponsored clinical studies.
- Appropriately resolved issues related to trial monitoring and management with guidance from the Supervisor.
- Responsible for the start-up, initiation, implementation, and management of clinical trials for the assigned sites.
- Collaborated closely with the entire study team, including the medical Monitor, Project Manager, and the entire in-house study team to ensure the successful execution of the clinical study.
- Conducted an evaluation of the site to effectively handle and perform a clinical trial, both scientifically and professionally.
- Tracked patient recruiting by contacting investigators as defined for the report and exploring possible risks and opportunities for the research.
- Coordinated and monitored site monitoring tasks and activities.
- Managed all facets of the clinical trial at all assigned clinical sites to ensure patient protection, comply with relevant safety standards and data integrity.
Clinical Research Coordinator
Johns Hopkins University
06.2017 - 05.2019
- Coordinated clinical studies in the medical research area. Developed an understanding of the requirements of the study protocol and obtained necessary information from physicians and study participants and recorded this information appropriately.
- Developed and maintained communication with the research manager, co-workers, principal investigators, and other internal personnel regarding study-related issues.
- Prepared for and met with pharmaceutical monitors’ site visits. Maintained professional relationships with external customers.
- Ensured all protocol-required procedures and visits occur according to specified guidelines.
- Ensured that drug dispensing is performed according to the protocol, documented on inventory forms/electronic records, and maintained and updated regularly.
- Responsible for all aspects of study termination, i.e., complete necessary documents/forms, the return of drugs to the drug company.
Education
Bachelor of Science - Industrial Relations and Personnel Management
University of Lagos
NigeriaPost Graduate Diploma - Strategic Management
Centennial College
Toronto, ON06.2024
Skills
Strong knowledge and practical application of ICH-GCP guidelines and relevant Standard Operating Procedures (SOPs)
Proficient in handling regulatory and IRB/REB submissions and addressing related inquiries
Strong command of FDA guideline, CRF Title 21, specifically sections (11, 21, 50, 54, 56, 310, 312,314)
Experienced in implementing risk-based monitoring strategies to ensure integrity and compliance in study
Experience with all phases of site visits (PSSV, SIV, IMV, and COV)
Excellent interpersonal skills with a keen eye for detail
Highly organized with effective time management abilities to meet tight deadlines
Demonstrated flexibility and adaptability in dynamic environments
Capable of working both independently and collaboratively within cross-functional teams
Thrives in fast-paced, ambiguous settings with shifting priorities
Exceptional communication skills, including written, verbal, and active listening
Extensive hands-on experience managing clinical trials across Phases I to III
Willing and able to travel up to 80% as required by study demands
Oncology: Leukemia, Lymphoma, Solid Tumor and Breast Cancer, Lung Cancer, Prostate Cancer
Ophthalmology: Diabetic-Retinopathy, Macular Degeneration
CNS: Dementia, Sleep Apnea and Migraines
Cardiovascular Disease: Hypertension, Stroke, Medical Device Cardiovascular
Immunology: Lupus
Neurology: Parkinson Disease, Multiple Sclerosis and Major Depressive Disorder
Infectious Disease: HIV/AIDS, Leprosy and HPV
Medical Device: Cardiac Pacemaker, IVD
CTMS: Impact and Medidata Rave
EDC: Medidata Rave, Oracle Inform, and Oracle Clinical
TMF: Veeva Vault and Wingspan
IWRS: Endpoint and Suvoda
TOOLS: MS Word, MS Excel, MS Power point, and MS Project
Certification
- Administrative Human Resources
- Administrative Professional Foundations
Accomplishments
Create it
Timeline
Hospital Corpsman Third Class
United States Navy Reserve
07.2025 - Current
Senior Clinical Research Associate
Merck
08.2023 - Current
Clinical Research Associate I/II
Syneos Health
06.2019 - 08.2023
Clinical Research Coordinator
Johns Hopkins University
06.2017 - 05.2019
Bachelor of Science - Industrial Relations and Personnel Management
University of Lagos
Post Graduate Diploma - Strategic Management
Centennial College