Penn State Health Associate Regulatory Protocol Review Committee - Hem Onc in Hershey, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Work Type: Full Time
Hours: 8:00a - 5:00p
Responsible to coordinate the Penn State Cancer Institute (PSCI) Protocol Review Committee (PRC) and institutional Data and Safety Monitoring Board (DSMB) meetings. The PRC is a standing, scientific peer review of new or amended clinical research protocols conducted at Penn State Medical Center (PSMC). The DSMB is an independent review of patient safety and treatment efficacy in the active PSCI clinical trials.
In addition, this individual will drive processes to ensure efficient and compliant PRC and DSMB. This regulatory role will assist clinical investigators with the initial PRC review. For investigator initiated studies, position will interface with Principal Investigators to ensure timely and accurate submissions of all required reports as per the Data Safety Monitoring Plan and maintaining compliance with both internal (e.g., ORA, IRB) and external (e.g., FDA, NCI) requirements..
Associates degree plus 1 year of administrative and/or regulatory experience in clinical trials, academic research or health care or an equivalent combination of education and experience required.
KNOWLEDGE, SKILLS, & ABILITIES:
Proficiency with Microsoft Office required as well as the ability to learn an internal clinical trials management application. Excellent organizational and time management skills required.
The ability to multi-task, prioritize, and work independently are required. Excellent written and verbal communication is required.
Knowledge of clinical trials management, including local and federal regulatory requirements preferred. SoCRA or ACRP Certification preferred.
If chosen for this position, you may be required to pass a Post Offer Employment Physical Exam in accordance with the measurements listed in the Work Task Analysis (WTA) report. This job description is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities.
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Union: Non Bargained