What are the responsibilities and job description for the Biospecimen Manager - WVU Cancer Institute (Clinical Research Trials) position at West Virginia University?
The WVU Cancer Institute, Clinical Research Trials Unit at West Virginia University is currently accepting applications for a Biospecimen Manager
About the Opportunity
This position is charged with general oversight of all biological specimen collection, banking and shipping activities at the WVU Cancer Institute Clinical Research Unit (WVUCI CRU). This includes the primary management of a banking database, supervision of biospecimen coordinators, design and oversight of all policies and procedures related to biospecimen collection and banking at WVUCI CRU, and resource for clinical research staff. They are responsible for providing quality assurance information regarding specimen collection, processing and shipping in grant and budgetary preparations for WVUCI clinical trials.
We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:
- 37.5-hour work week
- 13 paid holidays (staff holiday calendar)
- 24 annual leave (vacation) days per year (employee leave)
- 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
- WVU offers a range of health insurance and other benefits
- 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ’s.
- Wellness programs
What You'll Do
- Leading performance management and improvement efforts for the staff, time approvals, leave requests, work assignments etc.
- Ensures that systems are in place for the effective, efficient, and accurate conduct of biospecimen collection and management in qualified clinical trials.
- Works with WVUCI and WVUCI Clinical Research Unit Leadership, and WVU Human Resources (HR) to develop and implement new systems as needed.
- Responsible for the ongoing workload assessment and reassignment of work as needed, requisitioning new staff as necessary with the approval of WVUCI Leadership and WVU HR.
- Manages resolution for issues arising from the conduct of biospecimen management and clinical research activities. May involve departments within the Cancer Institute, WVU OHRP, Ruby Memorial Hospital and other entities at the WVU Health Science Center, as well as sub-site institutions participating in WVUCI investigator-initiated multi-site trials.
- Develops training and onboarding programs for biospecimen core staff and clinical research teams related to specimen collection, processing, banking, shipping and database management.
- Collaborates with WVU HR and WVUCI leadership to develop and update position descriptions.
- Establishes and reinforces clear, measurable performance expectations under the direction of the Biospecimen Core Director.
- Serves on internal WVUCI/ HSC committees for the creation of SOPs, workflows, and metrics. Collaborates with leadership and support staff to implement and change policies and/or procedures.
Biospecimen management duties
- Acts as resource for associated research staff regarding research banking and correlative processing.
- Evaluates new protocols as part of the PRMC committee and provides feasibility plus estimate of time and cost for correlative sample collection and processing.
- Participates in working groups and coordinates internal quality control activities in conjunction with internal Monitors and other related staff.
- Communicates monthly activity reports to the WVUCI CRU operations team to ensure core is reimbursed for efforts on clinical trials.
- Maintains required training and/or certification records to operate equipment and process biospecimens (i.e. Dangerous Goods, IATA shipping).
- Ensures staff are promptly and accurately completing study specific specimen tracking systems to maximize efficiency and streamline processes.
- Liaises, along with WVUCI CRU Administrative Director, internal and external entities that wish to conduct clinical trials with biospecimen collections at WVUCI (e.g. pharmaceutical companies, NIH, foundations, etc.).
- Provides data analysis and reports for Cancer leadership on banking activity as well as correlative processing for internal and sponsored clinical trials.
- Oversees the certification and maintenance of equipment (i.e. centrifuges, refrigeration/freezer) required to maintain lab space.
- Ensure Lab surroundings are maintained per WVU standards to include wash or discard dirty equipment and lab area as appropriate.
- Oversees inventory control on lab supplies for collection, processing, storage and shipment as needed to ensure adequate stock is available.
- Communicate with external sponsors regarding kit maintenance, storage and destruction procedures.
- Maintain accurate and thorough documentation to include the chain of custody of each sample from collection through shipment/analysis/destruction.
Tissue Bank Management - The Biospecimen Processing Core will maintain a human blood and tissue bank database and have primary responsibility in consent, collection and clinical data management. This would include:
- Obtain informed consent from research participants when applicable.
- Perform medical history screening for possible study enrollment.
- Collect bio-specimen samples from research participants and perform routine laboratory processing.
- Sample preparation may include centrifugation, pipetting, DNA/RNA extraction, white blood cell separation, tissue stabilization.
- Work in conjunction with the pathology departments (may be external to WVU medicine) for archived and Fresh tissue collection.
- Collaborate with interventional radiology, surgical staff or other clinical team for fresh tissue specimens to prepare for tumor biopsy per protocol. On hand during the tumor collection for any immediate required processing and ships the fresh tumor sample out to the corresponding lab.
- Maintains internal tissue bank database that includes clinical data metrics obtained through chart review.
- Update accrual information as needed into OnCore CTMS.
- Ensure compliance with and maintenance of Institutional Review Board protocols.
- Provide oversight for tissue bank personnel.
- Master’s degree in healthcare, biological sciences or a related field
- A minimum of five (5) years of experience in the following:
- Experience in Medical or research setting
- Familiarity with Clinical Research Desired
- Proficiency with Microsoft Office applications and/or EPIC electronic medical records.
Knowledge, Skills and Abilities
- Proficiency with word processing, spreadsheet and database applications required.
- Ability to multi-task with multiple processes occurring simultaneously.
- Skilled at working as a team member.
- Ability to prepare and update policy and procedures related to bio-specimen collection, preparation and storage of specimens.
- Should possess good written/oral communication and have knowledge of basic computer applications using Word and Excel.
- Excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and internal staff members. Communicates with physicians, patients, students and employees of WVU and Health Sciences Center.
- Working knowledge of appropriate patient assessment techniques and medical terminology.
- Knowledge of appropriate bio-specimen collection and processing techniques.
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to develop constructive and cooperative working relationships with others and maintain them over time.
- Basic chemistry lab skills as demonstrated by passing a high school chemistry course.
- Ability to analyze information and evaluate results to choose the best solution, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Ability to develop specific goals and plans, to prioritize, organize and accomplish tasks independently and through others.
- Ability to learn how to reproducibly use a pipette and maintain safe lab practices.
- Ability to be certified in phlebotomy.
Preferred Qualifications
- Familiarity with basic laboratory processes preferred.
- Phlebotomy certification required within six (6) months of start date.
West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.
From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.
At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values — service, curiosity, respect, accountability and appreciation — unite us as Mountaineers.
We are dedicated to creating an inclusive and engaging working environment and actively seek candidates who bring diverse ideas, approaches and experiences.
Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.
West Virginia University is proud to be an Equal Opportunity Employer and received an NSF ADVANCE award for gender equity. We value diversity among our faculty, staff and students and invite applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
