Clinical research Coordinator for Phase II, III, and IV clinical trials in accordance with the protocol, GCP, ICH, and the applicable regulatory requirements.
Sponsor: Managed and trained study coordinators, oversaw and coordinated the activities of the clinical trials. Assisted with the preparation of protocols, CRFs, and monitoring plans.
Coordinated the collection of study participant data from the hospital and pharmacy. This included research protocols, case report forms, informed consent forms, and case report form.
Train and manage clinical trial coordinators, including Principal Investigator, sub-investigators, and research assistants. Ensure compliance with protocol, GCP, ICH guidelines, good clinical practice (GCP), and FDA.
2-14 years of clinical trials Associate: NIH, United Kingdom, USA, CA. Responsibilities included: phlebotomy, IV, IM, SC, and investigational.
Managed the NRG Oncology study protocol, including but not limited to: Medical terminology, IRB submissions, drug accountability, and all aspects of the study.