Penn State Health Associate Regulatory II - Hem Onc Clinical Trials in Hershey, Pennsylvania

Penn State Health Milton S. Hershey Medical Center

Location: US:PA:Hershey

Work Type: Full Time

FTE: 1.0

Shift: Day

Hours: 0800 - 1700

JOB SUMMARY:

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.

MINIMUM QUALIFICATIONS:

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.

PREFERRED QUALIFICATIONS:

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.

Penn State Health is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please call 717-531-8440 between the hours of 8:30 AM and 4:30 PM, Eastern Standard Time, Monday – Friday, email hrsolutions@pennstatehealth.psu.edu or download our Accommodation Instructions for Job Applicants PDF for more detailed steps for assistance.

Union: Non Bargained