CHARLES EDEKI
Rosharon,Tx
Summary
Experienced oncology-focused Clinical Research Associate with over 10 years of experience supporting sponsor, CRO, and site-based clinical trials from study start-up through closeout. Skilled in remote and on-site monitoring, site management, protocol compliance, SAE reporting, TMF oversight, CRF review, EDC systems, regulatory documentation, and cross-functional clinical operations. Currently serving as a sponsor-side CRA II supporting radiopharmaceutical and theranostic oncology studies. Experienced in collaborating with investigators, study coordinators, Clinical Operations, Medical, Safety, Data Management, and CRO partners to support successful study execution, patient safety, data integrity, and regulatory compliance.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II
Perspective Therapeutics
01.2026 - Current
- Conduct remote and on-site monitoring visits for oncology and radiopharmaceutical clinical trials in compliance with ICH-GCP guidelines, sponsor SOPs, and protocol requirements.
- Review source documentation, imaging records, EDC data, laboratory data, and patient records to ensure data accuracy, completeness, and protocol compliance.
- Perform review and follow-up of protocol deviations, CAPA activities, eligibility verification, and site corrective actions.
- Collaborate closely with Clinical Operations, Medical, Data Management, Pharmacovigilance, and site teams to support successful study execution.
- Support SAE reporting activities, safety follow-up, and timely issue escalation to study leadership.
- Assist with TMF quality review, monitoring reports, follow-up letters, and site communication activities.
- Support radiopharmaceutical and theranostic oncology studies involving targeted alpha therapies and advanced imaging procedures.
- Review RECIST assessments, imaging timelines, dosing documentation, and study visit compliance.
- Provide ongoing site support and training related to protocol requirements, EDC data entry, and study procedures.
- Maintain strong working relationships with investigators, study coordinators, nuclear medicine teams, and CRO partners.
Site Engagement Lead
Perspective Therapeutics
05.2023 - 02.2026
- Served as the primary point of contact for assigned clinical trial sites supporting oncology studies.
- Managed site feasibility, site engagement, study start-up, and operational readiness activities.
- Supported site budgets, confidentiality agreements (CDAs), contract execution, and regulatory documentation processes.
- Coordinated communication between investigators, CRO partners, Clinical Operations teams, and sponsor leadership.
- Supported CRF review, data query resolution, site training, and study documentation activities.
- Assisted with protocol development, CRF development, and study operational planning activities.
- Supported SAE reporting processes, protocol compliance oversight, and issue escalation activities.
- Collaborated with sites to support enrollment readiness, study timelines, and operational efficiency.
- Contributed to onboarding, training, and mentoring of team members within Clinical Operations.
- Supported investigator identification, qualification, and recruitment activities for oncology studies.
Senior Clinical Research Associate
Molina Healthcare
03.2020 - 05.2023
- Oversaw clinical trial activities from study start-up through closeout while ensuring compliance with GCP guidelines and regulatory requirements.
- Reviewed and verified clinical trial data for accuracy, completeness, consistency, and protocol compliance.
- Collaborated with investigators, sponsors, and data management teams to resolve data discrepancies and study issues.
- Supported patient safety monitoring, adverse event reporting, and regulatory documentation activities.
- Coordinated and monitored study site activities to maintain study timelines and operational efficiency.
- Served as a primary point of contact between investigators, clinical teams, and sponsor stakeholders.
- Supported preparation of study reports, monitoring documentation, and regulatory submissions.
- Provided mentorship and training support to junior Clinical Research Associates and study personnel.
- Maintained compliance with sponsor SOPs, FDA regulations, and ICH-GCP requirements.
- Supported cross-functional collaboration activities to ensure successful study execution.
Clinical Research Associate II
AbbVie
01.2018 - 02.2020
- Conducted remote and on-site monitoring visits in accordance with protocols, Clinical Monitoring Plans, SOPs, and GCP requirements.
- Performed site qualification, initiation, interim monitoring, and closeout visits for assigned clinical studies.
- Reviewed regulatory documentation, patient records, CRFs, study databases, and source documentation for protocol compliance.
- Supported Clinical Trial Managers with study planning, site management, and operational activities.
- Maintained Trial Master File accuracy and supported study documentation management.
- Conducted site training activities related to protocol requirements and study procedures.
- Maintained positive working relationships with investigators, study coordinators, and sponsor stakeholders.
- Supported issue escalation, protocol compliance activities, and monitoring follow-up activities.
- Maintained current knowledge of FDA regulations, GCP guidelines, and assigned therapeutic areas.
Clinical Research Associate
Parexel
02.2016 - 01.2018
- Monitored safety of research participants and ensured informed consent procedures complied with local and federal regulations.
- Conducted site qualification, initiation, monitoring, and closeout visits to verify protocol compliance and study conduct.
- Reviewed study procedures, regulatory documentation, source documents, and drug accountability records.
- Supported project management activities including study planning, site management, and operational oversight.
- Maintained strong working relationships with investigators, study coordinators, and sponsor teams.
- Supported investigator identification, recruitment, and site qualification activities.
- Assisted Clinical Trial Managers with study documentation, site communication, and issue resolution.
- Ensured monitoring activities complied with sponsor SOPs, Clinical Monitoring Plans, and GCP requirements.
Clinical Research Coordinator
UT Health San Antonio
01.2014 - 02.2016
- Worked with principal investigators and sponsors to facilitate daily clinical trial activities and ensure protocol compliance.
- Collected and reviewed study data according to protocol requirements, CRFs, and operations manuals.
- Screened patient records and coordinated participant recruitment and enrollment activities.
- Performed patient assessments, monitored participant safety, and supported study visits.
- Supported IRB submissions, regulatory documentation, and research compliance activities.
- Performed quality control reviews and prepared reports demonstrating study findings.
- Collaborated with physicians, nurses, and research staff to support study execution and participant care.
Education
Master of Business Administration - MBA
Western Governors University
Utah02-2025
Bachelor of Science - Physics
Delta State University, Nigeria
Delta State11-2009
Skills
- Oncology research trials
- Radiopharmaceutical trials
- Site management
- Electronic data capture
- ICH guidelines
- Site monitoring
- Source document verification
- Coordinating site operations
- Team leadership qualities
Certification
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) – CITI Program (Issued Sep 2024 | Expires Sep 2027)
- ICH-GCP – NIDA Clinical Trials Network (Issued Jun 2023 | Expires Jun 2026)
Therapeutic Experience
Oncology (Melanoma, Ovarian, Colon, Gastrointestinal, Hematologic, Gynecologic), Radiopharmaceutical & Theranostic Trials, Neurology, Respiratory, Cardiovascular, Infectious Disease, and Medical Devices.
Timeline
Clinical Research Associate II
Perspective Therapeutics
01.2026 - Current
Site Engagement Lead
Perspective Therapeutics
05.2023 - 02.2026
Senior Clinical Research Associate
Molina Healthcare
03.2020 - 05.2023
Clinical Research Associate II
AbbVie
01.2018 - 02.2020
Clinical Research Associate
Parexel
02.2016 - 01.2018
Clinical Research Coordinator
UT Health San Antonio
01.2014 - 02.2016
Master of Business Administration - MBA
Western Governors University
Bachelor of Science - Physics
Delta State University, Nigeria