Clinical Research Services Section Director - Biorepository

Clinical Research Services Section Director

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 oversight of the clinical specimen processing core. This position plays a key role, in coordinating, managing, and tracking biospecimen collection and interacting with researchers requesting and receiving samples from the biorepository.

The successful applicant should have experience and knowledge of biorepository activities. The individual should have excellent oral and written communication skills, be highly organized and able to interact with all levels of the organization and with investigators. The position requires experience in research or clinical laboratory setting with knowledge of regulatory standards.

This key role will support the coordination, collection, management, and distribution of samples to and from the biorepository. The Biorepository Manager will be involved in the following activities:

• Reviewing quality control processes across centralized and satellite biobanks and make recommendations to leadership for improving quality standards for all College of Medicine biobanking operations.
• Ensuring IRB protocols are followed through the design and implementation of various sample collection activities.
• Implementing the quality management program (monitoring of key indicators, investigation of problems with corrective and preventative actions, maintenance of safety).
• Coordinate 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.
• Ensuring basic ethical standards related to biospecimen collection and distribution are upheld across the institution.
• Ensuring provision of educational programs, strategic planning, and research and development appropriate to the needs of the Institutional Biorepository.
• Ensuring 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. Ensuring that all persons preforming 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.

Minimum Education, Work Experience & Required Certifications

Master's Degree 3+ years of relevant experience; or an equivalent combination of education and experience accepted Required

Certifications:

None

Salary & Benefits

The salary range for this position, including all possible grades, is $68,200.00 - $. 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.