Adeyemi Adeyiga
Swedesboro,NJ
Summary
Experienced Senior Clinical Research Associate (SR CRA) with over nine years in clinical research, specializing in cardiovascular and medical device studies. Expertise in managing multiple study sites, ensuring regulatory compliance, and fostering strong site relationships. Adept at remote and on-site monitoring of clinical activities related to pacemakers, anticoagulation medications, coronary stents, and heart failure treatments. Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
Overview
12
12
years of professional experience
Work History
Regional Site Manager
Inseption Group
07.2022 - Current
- Oversee clinical study activities at multiple sites, ensuring regulatory compliance
- Conduct site visits (initiation, monitoring, and close-out)
- Develop and track site metrics for patient screening, enrollment, and compliance
- Ensure Essential Documents and Trial Master Files (TMF) are inspection-ready
- Monitor investigational product (IP) accountability, safety reporting, and protocol adherence
- Mentor junior CRAs and contribute to process improvements in clinical operations
Senior Clinical Research Associate (SR CRA)
PPD
01.2019 - 07.2022
- Managed cardiovascular medical device trials, ensuring data integrity and regulatory compliance
- Led pre-study, site initiation, monitoring, and close-out visits
- Ensured protocol adherence, patient safety, and regulatory document accuracy
- Conducted investigator meetings and site training on study-specific procedures
- Assisted in protocol development, regulatory submissions, and case report form (CRF) review
Clinical Research Associate II (CRA II)
Parexel
11.2016 - 01.2019
- Conducted site qualification, initiation, monitoring, and close-out visits for cardiovascular and CNS trials
- Ensured FDA and ICH-GCP compliance, data accuracy, and patient safety
- Resolved data queries and maintained electronic data capture (EDC) systems
- Acted as primary liaison between sponsors and study sites
Clinical Research Associate I (CRA I)
PPD
01.2014 - 11.2016
- Conducted remote and on-site monitoring for cardiovascular and medical device studies
- Evaluated regulatory submissions, patient recruitment, and case report form (CRF) completion
- Maintained Essential Documents and ensured protocol compliance
Clinical Research Coordinator
Northwestern University
01.2013 - 01.2014
- Assisted in coordination and site management for cardiovascular clinical trials
- Monitored regulatory compliance and reviewed informed consent procedures
- Ensured patient safety and adherence to Good Clinical Practices (GCP)
Education
Bachelor of Science - Biology
Cheyney University
Skills
- Clinical research
- Cardiovascular
- Medical device
- Remote monitoring
- On-site monitoring
- Study site management
- ICH-GCP guidelines
- FDA regulations
- Protocol compliance
- Regulatory documentation
- Data review
- Site audits
- Interpersonal skills
- Communication skills
- Cross-functional teams
- Domestic travel
Therapeuticareasofexpertise
- Cardiovascular, Pacemakers, Coronary Stents, Anticoagulation Medications, Congestive Heart Failure, Stroke, Parkinson’s Disease
- Medical Device, In Vitro Diagnostics, Cardiac Pacemakers
- Ophthalmology, Glaucoma, Dry Eye, Refractive Lens (Lasik)
- Oncology, Solid Tumor, CAR T Cell Lymphoma, Acute Myeloid Leukemia, Breast Cancer, Colon Cancer
- Rare Disease, Cystic Fibrosis
- CNS, Dementia, Schizophrenia
Technologyandsystemsexperience
- EDC Systems, Medidata Rave, Inform, Trialmaster, Datalabs, Medrio
- CTMS Platforms, Siebel, Impact, Seeibo Clinical
- TMF Management, Veeva Vault
- IWRS Systems, Suvoda, Endpoint
Skillsandcorecompetencies
- 9+ years of clinical research experience with a focus on cardiovascular and medical device trials.
- Extensive experience in remote and on-site monitoring and study site management.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and protocol compliance.
- Expertise in regulatory documentation, data review, and site audits.
- Excellent interpersonal and communication skills to liaise with cross-functional teams.
- Ability to travel domestically up to 80%.
Timeline
Regional Site Manager
Inseption Group
07.2022 - Current
Senior Clinical Research Associate (SR CRA)
PPD
01.2019 - 07.2022
Clinical Research Associate II (CRA II)
Parexel
11.2016 - 01.2019
Clinical Research Associate I (CRA I)
PPD
01.2014 - 11.2016
Clinical Research Coordinator
Northwestern University
01.2013 - 01.2014
Bachelor of Science - Biology
Cheyney University