Contributed by Cris Wells, EdD, MBA, MS, CCRP, RT (Director, Clinical Research Management Programs, Arizona State University)
As I stepped into my new office, I was overwhelmed by my eagerness and enthusiasm. It was 2003, this was my first day on the job, and I couldn’t believe how lucky I was to be a part of this “new” translational science and the discovery process of finding treatments for pancreatic cancer patients. I didn’t know exactly what I would be doing – the interviews had been vague about the details of the job, an attribute of start-up companies, I was told. Regardless, I was ready for a different challenge after leading oncology studies at a major hospital for the past 7 years. So when the principal investigator walked into my office with a 3 page document (protocol), and casually asked me to pull together a pancreatic cancer serum and DNA specimen collection, I disappointedly thought, “What? How difficult can this be?”
Many of you must be laughing aloud at my naiveté. Little did I know that I would be working countless hours at a desk covered with specimen tubes, shipping containers, IRB applications, flowcharts, budgets, consent forms, SOPs, freezer specs, scientific contacts, pathology contacts, and more! I discovered that even the most complicated oncology study didn’t compare with this “simple” 3 page protocol.
Fast forward 10 years (2013), a doctoral degree, a career in education, and a study volunteer for several biobanking studies – a colleague and I were discussing the continuing challenges of biospecimen collection when the possibility of offering a biospecimen repository administration certificate as part of Arizona State University’s Clinical Research Management (CRM) program arose as a topic. Was it something the community wanted, and was it a good fit for the CRM program? Our first step was to solicit community feedback through a survey sent to the Arizona Biospecimen Consortium members through the Arizona Biomedical Research Commission. The feedback was overwhelmingly positive in support of a certificate that would focus on administrative or business oversight, rather than the scientific or technical aspects of biospecimen collection. We started the University vetting processes shortly after the survey, and were rewarded with positive feedback and encouragement from the business, biology, research, health, and nursing departments and colleges.
Moving onto 2016, ASU launched the Biospecimen Repository Administration Graduate Certificate. Focused on the management and administrative aspects of biospecimen repositories, the certificate is directed toward individuals who will be managing the operations of a biobank. Topics include, personnel oversight, budgets, SOPs, stakeholder analysis, timeline development, collaboration, resource allocation, regulations, and more. The Certificate consists of 5 courses (or 15 credit hours) and is online. Students can take the courses in any order they choose once they complete HCR545, Foundations of Biospecimen Repository Administration. The course titles and a short description follow:
- HCR545, Foundations of Biospecimen Repository Administration – examines business processes underpinning the biospecimen repository industry.
- HCR546, Management of Biospecimen Repository Operations – examines the management processes supporting biospecimen repository operations.
- HCR547, Biospecimen Resource and Technology Management – examines the technology and resources required to maintain biospecimen repository operations.
- HCR548, Regulation and Ethics in Biospecimen Repository Administration – encompasses the ethical, regulatory and related quality issues that surface in the administration of a biospecimen repository.
- HCR549, Scientific Innovation and Biospecimen Repository Administration – examines how scientific advancements lead to a higher demand of prospectively collected “molecular- grade quality” biospecimens linked to rich clinical data, and the challenges this creates for the biospecimen repository administrator.
While the courses earn students a (stand-alone) graduate certificate, many of the courses are integrated into the Master of Science degrees in Clinical Research Management and in Regulatory Science in the College of Nursing and Health Innovation. In other words, the Certificate can be used as a springboard to an M.S. degree, with a little planning.
We realize that many ISBER members have a great deal of experience in managing and running biospecimen repositories, so this may not be a good fit for this segment of the ISBER group. However, if you are in this category, we are looking for people to serve on our advisory committee, to teach, and to partner with us in maintaining an excellent curriculum.
If you have questions, would like to discuss the program, or would be interested in possibly joining our team, please contact me at firstname.lastname@example.org.
Cris Wells is a Clinical Professor and Director of Clinical Research Management Programs at Arizona State University within the College of Nursing and Health Innovation’s master’s degree programs. A radiologic technologist and electrical engineer by training, Professor Wells has a long history of overseeing health care and research projects in basic, translational, and clinical research. Prior to joining ASU, she was Director of Clinical Research Programs at Gateway Community College of Maricopa County for six years, Director of Clinical Operations at TD2 (a division of the Translational Genomics Research Institute (TGen)) for three years, Director of the Western Regional Community Clinical Oncology Program and oncology research at Banner Health for seven years, and Supervisor of Neurobiology research at Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center for two years. Her engineering background centered on pacemaker design when working for Medtronic. She also served as the consumer representative on the Food and Drug Administration Medical Device Advisory Panel for four years. Professor Wells’ current interests are focused on workforce development and curriculum design of emerging research and health care professions, including biorepository administration and health care compliance.