Highly motivated clinical professional with 14 years of experience in effectively overseeing daily clinical activities and projects. Adept at leading and training cross-functional teams, managing budgets and maintaining strong relationships with internal/external stakeholders. Demonstrates excellent communication, analytical, and problem-solving skills to drive continuous improvement and innovation in clinical setting.
· Collaborated with multidisciplinary oncologists (Breast, Thoracic/Head & Neck, Genitourinary, Melanoma, Gynecologic, Gastrointestinal Medical Oncology, Leukemia, and Lymphoma/Myeloma, Interventional Radiology) for various operational activities on sponsored trials as well as correlative studies for investigator-initiated trials.
· Served as primary point of contact for operational management (start-up, accrual and close-out) of five phase I/II oncology trials per FDA, GCP and ICH guidelines demonstrating in-depth knowledge of clinical trials.
· Presented weekly safety review updates to sponsors & CROs, authored protocol annual review reports, cohort summaries, IRB continuing review reports and Grand Rounds presentations.
· Designed and conducted protocol specific training for physicians, laboratory technicians, nurses and data coordinators, mentored new clinical coordinators on departmental policies and general practices of clinical research.
· Built productive partnerships with contract research organizations (CROs), industry sponsors and external stakeholders by leading monthly presentations on institutional updates, study metrics and troubleshooting operational challenges.
· Reported adverse events to sponsor’s Drug Safety and Public Health department and other internal departments as appropriate per required guidelines.
· Maintained complex records and regulatory documents and records for research studies.
· Coordinated activities including study visits related to initiation and conduction of clinical trials.
· Prepared clinical tele-conference notes and minutes weekly for sponsor and clinical staff to discuss trial status, conduct, patient enrollment and safety.
· Developed and maintained a processing and tracking system for all protocol related pharmacokinetic and correlative studies including protocol calendars.
· Collaborated with database administrator and statistician to create study specific databases and requested reports.