Associate Regulatory II - Hematology Oncology Clinical Trials

Penn State Health Milton S. Hershey Medical Center

 

Location:  US:PA:Hershey

Work Type:  Full Time

FTE: 1.0

Shift: Days
Hours: Days

 

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:

 

Associates 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 fundamentally committed to the diversity of our faculty and staff. We believe diversity is unapologetically expressing itself through every person's perspectives and lived experiences. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information. 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