The Research Specialist will administrate and provide support for research and participation in clinical trials in a specialized regulatory function. The incumbent directs the processing and documentation of all activities related to Institutional Review Board (IRB) submission/review and may provide consultation and education to research staff and other healthcare professionals.
Directs the processing and documentation of all activities related to Institutional Review Board (IRB) submission/review.
Receives, reviews, and processes documentation of new study submissions to the IRB as well as to the systems Research Scientific Review Committees, Safety Committees and Research Conflict of Interest Committee.
Receives, reviews, and processes documentation of ongoing study submissions to the IRB, including safety reports, consent form changes, study amendments, Investigator Brochures, patient recruitment materials, and study completion forms.
Writes consent form revisions that are both complete and understandable to study participants and acceptable to sponsor and IRB.
Manages the IRB submission and monitoring process, including all initial and continuing review activities for approximately 10-12 active protocols per year.
Responsible for timely processing of study materials and continuing reviews and for communicating with the IRB to assure that materials are reviewed in a timely and appropriate manner.
Communicates with constituents and customers about pharmaceutical and medical device sponsored clinical trials and their processes.
Ensures that IRB committee recommendations are communicated to sponsors and Clinical Trials Office (CTO) staff and implemented in a timely and effective manner.
Communicates with sponsor regarding patient consent forms, approval letters, and other required forms.
Maintains communications with Clinical Trials Director, CTO research staff, IRB, M Health Fairview St. Johns Hospital Research Pharmacy, Fairview Research Administration (FRA) and sponsors on the status of studies.
Conducts sponsor monitor visits
Maintains investigator site file (paper or electronic)
Reviews files with monitor, corrects and updates files as needed
Follows CTO Monitor Letter Management Work Process Guideline (WPG)
Performs other tasks in support of the Clinical Trials team.
Understands and correctly acts on the needs of internal and external customers.
Attends CTO staff meetings and other meetings as required, and prepares reports and updates as required.
Supports audits performed by sponsors, IRB, University of Minnesota Human Research Protection Program (HRPP), FDA, or any other regulatory bodies.
Bachelors degree in health-related field or 4 years experience in a medical or scientific field
Experience in a research setting
Working knowledge of Microsoft applications (Word, Access, Excel)
Masters degree or advanced clinical degree preferred.
Prior experience in FDA regulated trials, both pharmaceutical and medical device, cardiology expertise preferred.
List position requirements not described above (e.g., computer hardware/software, other office equipment, laboratory equipment, prior supervisor experience, etc.)
Excellent customer service skills, proficient in the English language, good attention to detail, ability to problem solve effectively, ability to follow policies and procedures and excellent communication skills.
Together with the University of Minnesota and University of Minnesota Physicians we have created M Health Fairview. M Health Fairview is the newly expanded collaboration among the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine — expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.
Fairview Health Services (fairview.org) is an award-winning, nonprofit health system providing exceptional care across the full spectrum of health care services. Fairview is one of the most comprehensive and geographically accessible systems in the state, with 10 hospitals—including an academic medical center and long-term care hospital—serving the greater Twin Cities metro area.
Its broad continuum also includes 60 primary care clinics, specialty clinics, senior living communities, retail and specialty pharmacies, pharmacy benefit management services, rehabilitation centers, counseling and home health care services, medical transportation, an integrated provider network and health insurer PreferredOne. In partnership ...with the University of Minnesota, Fairview’s 32,000 employees and 2,400 affiliated providers embrace innovation to drive a healthier future through healing, discovery and education.