The Early Drug Development Project Manager will be an integral member of the research team supporting early drug development clinical trials. This position provides project coordination for the early drug development team and performs study coordination and data management activities with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting.
Actively participates in the review, planning, and implementation of clinical trials
Coordinates oncology clinical trials including but not limited to reporting protocol activities, accrual data, adverse event monitoring & reporting, study drug management, research sample management, and overseeing accurate and timely data management activities Collaborates with the study investigators to determine eligibility of patients to participate in clinical trials
Participates in the informed consent process for research participants and supports enrollment into clinical trials. Coordinates research activities across the team and for individual study participants
Collects and documents clinical information (data) from study participants. Provides general clinical research and protocol-specific training to research staff as well as other Jefferson employees as needed. Provides patient education regarding research study.
Interacts with consortium members, organizes meetings and communicates with participating institutions, tracks and records progress, schedules meetings, records and distributes minutes.
Minimum of a bachelor’s degree with three years of clinical research experience or Master’s degree with one year of clinical research experience. Nursing Diploma or Associate's Degree in Nursing or BSN preferred. Experience in early drug development /Phase 1 clinical trials and some management experience preferred.
About Thomas Jefferson University and Jefferson Health
The Coordinator manages and oversees twice-monthly Protocol Review Committee (PRC) meetings and quarterly Data and Safety Monitoring Committee (DSMC) meetings for the Sidney Kimmel Cancer Center (SKCC). Manages and coordinates all quarterly DSMC meetings which include partial completion, collection and distribution of principal investigator (PI) reports for IITs, medical monitor reports, reviews a...dverse event/serious adverse event logs submission and reviews all corresponding audit corrective and preventative action plans for the quarter; records and disseminates DSMC meeting minutes.Collaborates with the Chair of the DSMC to oversee the assignment of Medical Monitors to new SKCC trials.Manages and coordinates twice-monthly PRC meetings, which includes documenting reviewer comments, distributing decision emails, and monitoring the progression of trials in need of revision.Manages the PRC email inbox and all correspondence with PIs regarding protocol approvals, amendments, and stipulations. Executes decisions regarding expedited approval and studies needing administrative approval.Tracks low accruing trials and is responsible for presenting trial accrual history to the PRC. Assigns PRC reviewers to studies, disseminates meeting agendas, and maintains attendance tracking log.Trains all new PRC members on review processes and Jeff Trial submission.Assists the Quality Assurance and Process Improvement Unit and the Protocol Support Unit with administrative responsibilities.Bachelor’s degree required. Bachelors Degree Required. Minimum of 3 years’ experience in Clinical Research or Regulatory Affairs. Please apply online at www.jefferson.edu/careers and reference job ID# 9208233.