The Clinical Research Specialist plays a critical role in the Clinical Research Support Center (CRSC) by advising and educating investigators through the feasibility and navigation process. This role will help investigators maneuver the complicated clinical research start-up process at the University of Minnesota. The Specialist will develop templates and guidelines, informed by federal regulations and local policies and procedures, for use by investigators and the study teams in support of clinical research goals and the advancement of research projects. The Specialist collaborates with investigators and engages project stakeholders to identify potential design and operational barriers and solutions. Additionally, the Specialist is responsible for gathering information required for the clinical research feasibility assessment, distributing the information, and is responsible for presentation of the protocol to the cross-functional Feasibility Assessment team.
Essential Functions or Job Duties
(40%) Clinical Research Navigation
Develop and drive comprehensive timelines, project plans, and resource identification to manage and meet project deadlines. Understand project goals and advise on strategies for meeting the goals.
Serve as the content expert and provide customized and knowledgeable guidance to faculty and staff in the navigation of clinical research process, through knowledge of federal and internationally recognized research regulations, research ethics, institutional policies and clinical research principles.
Educate and advise researchers on the study management process, from start-up to closeout.
Work with study teams, stakeholders and clinical partners to optimize research study management processes and procedures so that research occurs in a compliant, rapid and efficient manner within a patient-centric framework.
Develop and drive the research project plan, bring applicable individuals into the project team.
Serve as the single point of contact for projects within the CRSC.
Schedule, lead, and document regular project team meetings
Monitor project status
Facilitate planning for multiple competing projects across many departments and medical disciplines/specialties.
(40%) Feasibility Assessment Management
Lead the feasibility process for assigned projects coming into the CRSC. Collaborate with the team to make modifications and enhancements to the process as necessary.
Upon assignment of a clinical research study, review and understand study; meet with investigator (and study team) to better understand the study protocol and goals.
Identify appropriate stakeholders and provide relevant study information to them for their assessment of capability to conduct the study. Ensure all stakeholders take part in the feasibility assessments, managing a reasonable review timeline. Follow-up with stakeholders to obtain missing information or feedback. Follow-up with investigator (or study team) to solicit additional materials needed by stakeholders. Track and report stakeholder feedback to investigator.
Work with appropriate stakeholders to identify potential hurdles and challenges that may jeopardize performance of the project, and recommends course corrections.
Serve as liaison between Feasibility Assessment team/stakeholders and investigator/study team.
Responsible for the presentation of the study to the Feasibility Assessment team, sharing the insights for stakeholders not present in person. Lead the discussion of the review, with prepared questions/comments regarding areas of concern or recommendations for key milestone or stopping points. Document Feasibility Assessment team review and summary.
If feasibility team review results in the need for additional follow-up with investigator/study team, the Specialist is responsible for all follow-up activities.
Communicate results of Feasibility Assessment team to investigator (and Department as needed). For studies that are deemed feasible and are ready to begin study initiation, ensure communication of key milestones and stopping points to investigator, as well as facilitate the transition of the project to the appropriate Clinical Research Coordinator, or study team.
Conduct metrics and quality assurance monitoring of projects and reporting to investigator and Department through trial execution to closeout.
(10%) Education, advisement and process improvement
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.
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.
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
Educate investigators on the protocol development process
Navigate through complex issues independently utilizing extensive clinical research experience to identify creative solutions.
Identify systemic gaps and collaborate with appropriate stakeholders to improve processes. Serve as a subject matter expert in the process of modifying practices and procedures to improve efficiency and quality. Search for better ways to effectively achieve end results.
(10%) Multi-site and Trial Innovation Center Liaison
Serve as an institutional liaison on multi-site collaborations as applicable.
For CTSA consortium studies that are already deemed feasible, work with appropriate UMN/Consortium managers to facilitate the stakeholder review and development of an implementation plan. Responsibilities include identification of all necessary stakeholders, facilitation of stakeholder team meetings, and communication back to manager on issues/concerns.
Assist investigators who are interested in using a CTSA consortium mechanism by making the appropriate resource connections.
Work with UMN/Consortium managers to develop tools, best practices, and resources to better facilitate the involvement of UMN investigators in Consortium-wide studies. Gather feedback from investigators and stakeholders to make recommendations.
The employer reserves the right to change or assign other duties to this position.
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BA/BS with at least 6 years of experience or advanced degree with 4 years of experience or a combination of related education and work experience to equal ten years.
Four years’ experience with clinical and/or translational research.
Ability to work with investigators of all experience levels.
Ability to work with senior level administrators as well as technical staff.
Experience in management of resources and research projects.
Strong organizational skills, including evidence of ability to multitask.
Excellent verbal and written communication skills.
Advanced degree in health, public health, or other biomedical disciplines.
Familiarity with academic medical centers, particularly the University of Minnesota system and processes strongly preferred.
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA), or equivalent (i.e., RAC)
Advanced level skills in Microsoft Word and Microsoft Excel.
Experience leading teams and delegating or assigning work tasks.
Experience working with diverse populations.
Experience with federal grant mechanisms, including NIH.
Demonstrated experience with public speaking.
Experience conducting feasibility assessments for clinical research studies.
Experience working in a CTSI/CTSA.
About University of Minnesota
The University of Minnesota, Twin Cities is a public research university in Minneapolis and Saint Paul, Minnesota.