Clinical Research Services Section Director - Biorepository

About the role

The Penn State College of Medicine in Hershey, PA is seeking a Clinical Research Services Section Director. This position will supervise all aspects of sample collection, processing and storage for the Penn State Institutional Biorepository and oversee the clinical specimen processing core.

Responsibilities

• Supervise all aspects of sample collection, processing and storage for the Penn State Institutional Biorepository and oversee the clinical specimen processing core.
• Coordinate, manage, and track biospecimen collection and interact with researchers requesting and receiving samples from the biorepository.
• Review quality control processes across centralized and satellite biobanks and make recommendations to leadership for improving quality standards for all College of Medicine biobanking operations.
• Ensure IRB protocols are followed through the design and implementation of various sample collection activities.
• Implement the quality management program (monitoring of key indicators, investigation of problems with corrective and preventative actions, maintenance of safety).
• Cook with various stakeholders including Clinical Trials Office and oversight and advisory committees to understand and evaluate evolving needs and capabilities of biorepository users.
• Ensure compliance with relevant industry standards and government regulations.
• Ensure basic ethical standards related to biospecimen collection and distribution are upheld across the institution.
• Ensure provision of educational programs, strategic planning, and research and development appropriate to the needs of the Institutional Biorepository.
• Ensure that there are sufficient personnel with adequate training and experience to meet the needs of the biorepository and that such training and experience is recorded.
• Ensure that all persons performing delegated functions are qualified to do so and that delegated functions are properly carried out in accordance with CAP and CLIA guidelines.
• Responsible for the financial planning and management of the biorepository, including budgeting, pricing, billing, procurement and forecasting.

Requirements

• Master's Degree
• 3+ years of relevant experience; or an equivalent combination of education and experience accepted
• Required Certifications: None

Qualifications

Experience and knowledge of biorepository activities. Excellent oral and written communication skills, highly organized, able to interact with all levels of the organization and with investigators. Experience in research or clinical laboratory setting with knowledge of regulatory standards.

Skills

Experience in research or clinical laboratory setting with knowledge of regulatory standards. Excellent oral and written communication skills, highly organized, able to interact with all levels of the organization and with investigators.

Benefits

Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our Benefits Page.

Pay

The salary range for this position, including all possible grades, is $72,300.00 - $108,444.00.

Schedule

This position is funded for 1 year(s); continuation past 1 year(s) will be based on university need, performance, and/or availability of funding.