Associate Regulatory II - Hematology Oncology Clinical Trial
Penn State Health
Location: Hershey, Pennsylvania
Admin / Clerical
Internal Number: 3619
Penn State Health Milton S. Hershey Medical Center
Location: US:PA:Hershey Work Type: Full Time FTE: 1.0 Shift: Day Hours: 8:00AM-4:30PM
SUMMARY OF POSITION:
Responsible to assist clinical investigators with the implementation of all Cancer Institute clinical research protocols, to include administrative and regulatory aspects of study start-up, maintenance, and closure. Responsible for maintaining compliance with both internal (e.g., ORA, IRB) and external (e.g., FDA, NCI) requirements. This individual will drive processes to ensure efficient and compliant study activation and maintenance, with attention to metrics driven goals for productivity. They will ensure all files are maintained in an audit-ready fashion.
Associate's degree plus 3 years 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 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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