The Clinical Research Specialist plays a critical role in the Clinical Research Support Center (CRSC) by advising and educating investigators through the start-up process, from study concept to activation. This role will help investigators maneuver the complicated clinical research start-up process at the University of Minnesota. The Specialist collaborates with investigators and engages experts to identify potential design and operational barriers and solutions.
(50%) Study Planning & Protocol Development â— Develop and maintain strategic relationships with PI/study teams, departments and CRSC experts to ensure collaboration. â— Oversee development of study protocol; review protocol for completeness, feasibility, compliance and optimal design for study success. â— Serve as the single point of contact for the investigator and study team for projects within the CRSC; fostering navigational oversight to move study planning efforts forward. â— Upon assignment of a clinical research study, lead efforts to review and understand the study protocol, goals and needs. â— Coordinate the preparation of study documents by leveraging CRSC experts. Documents may include, but is not limited to, protocol, informed consent form, recruitment materials, as required. â— Prepare study teams for successful ancillary reviews by leveraging CRSC experts and external collaborators. Experts and collaborators may include, but are not limited to, HRPP MedReg, SPA, HIPCO, FRA, OnCore, etc. â— Lead the feasibility review process for assigned projects coming into the CRSC. Collaborate with the team to make modifications and enhancements to the process as necessary. â— Manage and lead cross-functional teams including statistics, informatics, regulatory, and clinical partners. â— Ensure that the PIs/Study teams meet or exceed the timelines and deliverables assigned to them. â— Navigate through complex issues independently utilizing extensive clinical research experience to identify creative solutions for issue resolution. â— Ensure compliance with all applicable regulatory standards (IRB, FDA, GCP, UMN or Fairview policies) related to clinical research.
(25%) Facilitate rapid study activation â— Develop and drive comprehensive study start up timeline. Ensure study start up activities are completed to meet study timelines in collaboration with PIs, study teams and CRSC experts. Advise on strategies for meeting the goals, including plans to address potential timing risks/gaps. â— Liaise with Regulatory Affairs, Pre-award, Informatics, Clinical Partners and other CRSC team members to enable rapid clinical study start up. â— Identify issues before they become critical. Work through their resolution in collaboration with the study team and CRSC experts. â— Schedule, lead, and document regular project team meetings. â— Monitor project status. Ensures timely communication of study status to relevant stakeholders.
(10%) Education and advisement â— Educate and advise researchers on the study management process, from start-up to closeout. â— Serve as the content expert and provide customized and knowledgeable guidance to faculty and staff in the navigation of clinical research processes, through knowledge of federal and internationally recognized research regulations, research ethics, institutional policies and clinical research principles. â— Advise on the logistical implication of the resources required to conduct clinical research projects, including health data informatics, finance, biostatistics, research coordinators, biological sample management, subject recruitment, and various University committees that review and approve clinical research. Facilitate the connection between investigator/study teams and the appropriate experts. â— Assist departments in leveraging centrally available CTSI research resources in order to drive efficiencies in research administration and execution. Facilitate sharing of research insights, best practices and education opportunities
(10%) Initiatives and process improvement â— Identify fundamental issues or systemic gaps pertaining to study start up at the University, provide in-depth analysis and recommendations on process improvements. â— Contribute and/or lead initiatives within the CRSC and/or CTSI aiming at modifying practices and procedures to improve efficiency and quality. â— Develop new opportunities for the CRSC whenever possible, participate in new CRSC development activities including presentations. â— Create and implement clinical research tools and best practices, needed during the planning of feasible clinical research studies, to maximize the efficiency and conduct of research projects.
(5%) Other â— Provide regular project level reporting for operational metrics, dashboards and other efforts
The employer reserves the right to change or assign other duties to this position.
Required Qualifications â— BA/BS with at least 6 years of experience or advanced degree with 4 years of experience. â— Experience must include four years’ experience with clinical and/or translational research.
Preferred Qualifications â— Advanced degree in health, public health, or other biomedical disciplines. â— Familiarity with academic medical centers, particularly the University of Minnesota system and processes strongly preferred. â— Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA), or equivalent (i.e., RAC). â— Advanced level skills in Microsoft (i.e. Word, Excel) and Google products. â— Experience working in a CTSI/CTSA. â— Experience working in managing multiple clinical studies with proven results in study activation â— Experience with clinical research protocol development. â— Experience in developing a new program/service or expanding an existing program/service. â— Experience communicating with medical center faculty, staff and clinicians in a professional setting. â— Experience developing manuscripts, abstracts, posters or other presentations for professional or academic audiences.
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.