Abayomi Ojutalayo
Peabody,MA
Summary
Experienced Clinical Research Associate with 13+ years of experience in the clinical research industry of which 8+ years are clinical trial monitoring experience. Completed work on trials from start-up to close-out and experienced in conducting PSSVs, SIVs, IMVs, and COVs. Has served 3 years as a visit leader and mentor for co-workers. Well versed with site feasibility, site selection/initiation/monitoring/close-out visits, study metrics tracking, development of monitoring tools, EDC, GCP/ICH). Therapeutic experience includes; Oncology, Hematology, Endocrinology, Cardiovascular, Rheumatology, Osteology, Respiratory. Experienced in monitoring response of solid tumors using RECIST v1. 1 through study primary and secondary objectives as Clinical Research Associate II.
Overview
13
13
years of professional experience
Work History
Senior Clinical Research Associate
ICON (Former PRA Health And Sciences)
03.2021 - 11.2023
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
- Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required to ensured site conducts Clinical Trials according to Protocol, GCP, and FDA regulation
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Clinical Research Associate II
PRA Health & Science
03.2019 - 03.2021
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Clinical Research Associate II
SYNEOS HEALTH, Former Inventiv Health
05.2017 - 03.2019
- Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance
- Assisted the Regional Clinical Trial Manager with weekly Data Entry report, eCRF guidelines and assisting other CRA’s with protocol question and concerns
- Reviewed completion of proper informed consent procedures
- Ensured accurate data reporting via review of site source documents and medical records
- Interpreted data to identify protocol deviations and risks to subject safety/data integrity
- Generated queries and managed resolutions with site personnel
- Performed investigational product accountability as per the protocol and Study Monitoring Plan
- Obtained, reviewed, and process essential regulatory and administrative documents
- Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
- Documented activities via confirmation letters, follow-up letters, trip reports, communication logs
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required to ensure site conducts Clinical Trials according to Protocol, GCP, and FDA regulation
Clinical Research Associate
Inventiv Health
05.2015 - 05.2017
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Supported development and delivery of department training to maximize success of clinical research.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required to ensure site conducts Clinical Trials according to Protocol, GCP, and FDA regulation
Practice Manager
Access Primary Care
09.2010 - 05.2015
- Assisted CRAs with TMF submission and Query Resolution
- Created and distributed Study team meeting minutes
- Initiated, managed, and coordinated various clinical research projects and provided project specific administrative support
- Scheduled and participated in monitoring and auditing activities
- Conduct independent study coordination and screen potential patients for protocol eligibility
- Acted as a liaison between the physician, employee, and patient in a clinical setting and business setting
- Renewed and maintained records for physician’s federal and state licenses
- Managed all aspects of multi-physician medical practice and office logistics from physician- employee-patient scheduling, network connectivity, billing, insurance, physician contracting with insurance companies-independent physician associations-hospitals, purchasing, marketing, payroll, reconciling practice financials for accountants.
- Managed daily practice operations to optimize appointment scheduling, patient records management and billing functions.
- Provided outstanding support to entire staff which helped improve process flow and boosted efficiency.
Education
MBA - Health Care Management
Southern New Hampshire University
Manchester, NH08.2013
Bachelor of Arts - Biology
Kean University
Union, NJ08.2010
Skills
- Documentation Requirements
- Site Investigations
- Site Management
- Database Locking
- Monitoring Visits
- Site Preparation
- Clinical Trials and Research
- Site Evaluations
- Data Integrity
- Good Clinical Practice
- Protocol Understanding
- FDA Regulations
Accomplishments
- Developed and managed practice’s in-house billing and collections department increasing revenue from deficit to over 100% accounts receivable in 1 year of management.
- Performed as a Lead CRA for the sponsors priority study.
Timeline
Senior Clinical Research Associate
ICON (Former PRA Health And Sciences)
03.2021 - 11.2023
Clinical Research Associate II
PRA Health & Science
03.2019 - 03.2021
Clinical Research Associate II
SYNEOS HEALTH, Former Inventiv Health
05.2017 - 03.2019
Clinical Research Associate
Inventiv Health
05.2015 - 05.2017
Practice Manager
Access Primary Care
09.2010 - 05.2015
MBA - Health Care Management
Southern New Hampshire University
Bachelor of Arts - Biology
Kean University