ENIOLA AKINRINDE MD. MPH
New York,NY
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports while maintaining compliance with ICH/GCP guidelines. Proven expertise in monitoring investigator sites, conducting various visit types,and managing complex clinical trials across various therapeutic areas.
Overview
9
9
years of professional experience
Work History
Senior Clinical Research Associate
IQIVIA
11.2022 - Current
- Monitored approximately 18 investigator sites with risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills
- Conducted on-site and remote monitoring activities to ensure data accuracy through SDR, SDV, and CRF review
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Assessed investigational product through physical inventory and records review
- Documented observations in reports and letters using approved business writing standards
- Escalated deficiencies and issues to clinical management, ensuring timely resolution
- Maintained regular contact between monitoring visits with investigative sites
- Participated in investigator meetings and contributed to initiation of clinical trial sites
- Conducted trial closeout and retrieval of trial materials
- Ensured essential documents were complete and in place according to ICH-GCP and regulations
- Provided trial status tracking and progress reports to Clinical Team Manager
- Mentored junior-level CRAs, acted as Lead CRA, and served as resource for new employees
- Facilitated effective communication between investigative sites, client company, and project team
- Responded to company, client, and regulatory requirements/audits/inspections
- Completed administrative tasks such as expense reports and timesheets.
Clinical Research Associate II
Jounce Therapeutics
03.2021 - 11.2022
- Conducted Site Selection, Site Initiation, Routine Monitoring, and Close Out Visits
- Monitored investigator sites, managed complex studies, and ensured adherence to GCP
- Coordinated and monitored different sites, including PSSV, SIV, IMV, and COV
- Performed source document verification, query resolution, and IP accountability assessments
- Developed and submitted accurate trip reports according to Sponsor and CRO requirements
- Tracked enrollment and study-specific status reports, ensuring study goals were met
- Conducted study-specific training with the project team and attended sponsor calls
- Updated applicable tracking systems and maintained collaborative relationships with sites
- Conducted routine monitoring visits in accordance with the clinical monitoring plan
- Assisted in the preparation of project publications/tools and contributed to process improvement.
Clinical Research Associate I
Parexel International
01.2020 - 02.2021
- Coordinated with specialists to connect members to healthcare providers
- Completed monitoring activity documents and verified SAE reporting
- Conducted source document verification, query resolution, and essential document reconciliation
- Worked independently, implementing and monitoring clinical trials
- Maintained communication with study sites, providing updates and contact reports to sponsor
- Reviewed and verified accuracy of clinical trial data, onsite or remotely
- Assessed qualifications of potential investigative sites, initiated and closed clinical trials.
Clinical Research Coordinator/ Enrollment Specialis
Richmond University Medical Center
10.2018 - 01.2020
- Independently coordinated, conducted, and documented visits and protocol-specific testing/interviews for minimal risk studies, adhering to study protocols, clinical department operational plans, and standard operating procedures (SOPs)
- Managed and updated study documents, and CRF adequacy with protocols/protocol amendments, and assisted with rationalizing and documenting quantitative and qualitative data collection needs
- Supported safety of research subjects, identified & reported adverse events, and
- Serious adverse events, filed SAE report forms
- Scheduled patient study visits, reviewed protocols, and participated in study team meetings
- Processed study payments, updated subject compensation tracker, and assisted in study close-out
- Experience working with Clinical Trials Data Capturing Systems EDC, Clinical Trial
- Management Systems CTMS, and Electronic Trial Master File (eTMF)
General Practitioner
Olabisi Onabanjo University Teaching Hospital
08.2016 - 08.2018
- Performed routine check-ups, vaccinations, screenings, and health education
- Accurately diagnosed medical conditions and developed evidence-based treatment plans
- Managed and monitored chronic conditions, collaborating with patients to improve disease management
- Collaborated with patients to set treatment goals, adjust medications as needed, and provide ongoing support to improve disease management and quality of life
- Effectively communicate medical information to patients addressing their concerns, and provide clear instructions for follow-up care.
Physician Intern
Ring Road State Hospital
07.2015 - 07.2016
- Led comprehensive management of in-patients across multiple medical specialties during clinical rotations, resulting in improved patient outcomes and seamless continuity of care
- Suggested primary investigations and treatment plans following discussion and approval by senior Physician
- Follow up on implementation of prescribed course of treatment, obtain results of all ordered investigations, document development of any complications that may ensue, and plan discharge and follow-up
- Collaborated with healthcare professionals, engaged in clinical meetings and seminars, case presentations, and morbidity & mortality meetings
Education
Master of Public Health - Biostatistics And Epidemiology
Monroe College
New York, NY12.2020
M.D. - Medicine
Ivano- Frankivsk National Medical University
Ukraine06.2015
Skills
- EDC; Classic, Inform, RAVE, Veeva Vault
- CTMS; Oracle, Insight, Mac OS
- SDR, SDV, and CRF review
- Communication & Project team collaboration
- Process improvement initiatives
- Root cause analysis & Report Writing
- Critical thinking and problem-solving
- Team leadership qualities
- Clinical trial close-out
- Site Management
- SOP adherence
- Completing Regulatory Documents
Therapeutic Areas
- Cardiovascular (Hypertension, Acute Myocardial Infarction, Congestive Heart Failure)
- Neurology (Amyotrophic Lateral Sclerosis, Epilepsy)
- Oncology (Solid Tumor, Melanoma, Breast Cancer, Prostate Cancer, Lung Cancer)
- Respiratory (COPD)
- CNS (Alzheimer’s Disease)
- Covid-19
Timeline
Senior Clinical Research Associate
IQIVIA
11.2022 - Current
Clinical Research Associate II
Jounce Therapeutics
03.2021 - 11.2022
Clinical Research Associate I
Parexel International
01.2020 - 02.2021
Clinical Research Coordinator/ Enrollment Specialis
Richmond University Medical Center
10.2018 - 01.2020
General Practitioner
Olabisi Onabanjo University Teaching Hospital
08.2016 - 08.2018
Physician Intern
Ring Road State Hospital
07.2015 - 07.2016
Master of Public Health - Biostatistics And Epidemiology
Monroe College
M.D. - Medicine
Ivano- Frankivsk National Medical University
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