ONCOLOGY CLINICAL TRIALS, SITE MANAGEMENT, MONITORING
- 9 years of pharma clinical trials management experience; 14 years as a physician.
Oncology Clinical Trials Phases 1-3 (breast, hepatic, renal, prostate, GI, melanoma); Study Protocols; Site Selection, Management, and Monitoring; Sponsor / KOL Relationships; Study Forms and Documents; Vendor Management; Budgets and Contracts; Study Best Practices (including compliance / adherence and regulatory requirements); and On-site Data Management. MD from University of Ibadan in Nigeria.
Senior Site Manager, InSeption Group
Responsible for clinical study conduct: site selection, qualification activities, and management; field monitoring; compliance/regulatory requirements; good clinical practices; follow-up reports; and relationship building with stakeholders. Liaise with KOLs and therapeutic area experts. Review budgets and contracts. Liaise with data management to verify data, distribute and track materials and supplies, and provide feedback on protocols, informed consent materials, clinical monitoring plans, management plans, and trial recruiting materials. Verify materials and data integrity; assist site personnel with internal audits and regulatory inspections; and perform ongoing follow-up. Track patient recruitment with investigators to asses risks and opportunities. Work with labs to confirm adherence to the protocol and confirm relevant documentation was current. Ensure distribution of interim safety reports to EC/IRBs, assemble documents for the Sponsor file, assist in the organization of meetings (investigator, sponsor, kick-off, face-to-face), and make presentations at meetings.
Senior Clinical Research Associate, Chiltern
Responsible for clinical monitoring activities of sites to ensure quality and integrity of data, compliance with Chiltern’s / Sponsor’s SOPs, ICH GCP, and regulatory requirements. Prepared and conducted all site visits, including qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits. Identified potential centers for proposed studies. Tracked patient recruitment with investigators to asses risks and opportunities. Dealt with laboratories to confirm adherence to the protocol and confirm relevant documentation was current. Distributed and tracked clinical trial supplies, assisted with protocol design and Case Report Form design and tracking, liaised with data management, ensured distribution of interim safety reports to EC/IRBs, assembled documents for the Sponsor file, and assisted in the organization of meetings (investigator, sponsor, kick-off, face-to-face) and presented at meetings.
Clinical Research Associate, Occidental Pharmaceuticals
Responsible for all areas of routine monitoring of multiple investigational sites, including monitoring visits. Performed investigator recruitment and start-up activities (preparation of site study supplies, site qualification visits, and site initiation visits), as well as site monitoring visits, and close-out visits. Monitored visit reports and site correspondence. Monitored clinical trials to confirm that all protocols, ICH GCPs, FDA regulations, and SOPs were met. Confirmed proper documentation and reporting of Adverse events (AEs), serious adverse events (SAEs), and IND safety reports to sponsor and IRB. Documented findings for monitoring visits, maintained and updated issue tracking log, and notified applicable personnel of findings requiring action. Assisted Project Manager in tracking key study-wide metrics, such as protocol deviations, SUSARs, IND safety reports, etc. Mentored junior level CRAs.
Honorary Senior House Officer, Lewisham Healthcare NHS Trust, Lewisham Hospital, UK
Admitted and treated patients in clinic, conducting ward rounds and participating in attending rounds. Supervised medical students.