Career Center

Are you passionate about enhancing the way research is conducted to make a meaningful impact on people’s lives? Leverage your clinical research experience in the Clinical and Translational Science Institute (CTSI) where you will be a part of a team accelerating discoveries toward better health by providing a comprehensive infrastructure of research services, training, grants, tools, and more.

The Clinical Research Associate plays a critical role in the Clinical Research Support Center (CRSC) within the CTSI by supporting investigators through protocol development and start-up processes, from study concept to activation. This role will help investigators maneuver the complicated clinical research start-up process at the University of Minnesota. The Associate assists in supporting investigators and engages experts to identify potential design and operational barriers and solutions. The Associate works under the mentorship and guidance of the Research Preparation Group’s Clinical Research Specialists (CRS) and supports them in process improvement and developmental initiatives.

Essential Functions or Job Duties

(60%) Study Planning & Protocol Development
● Develop professional relationships with investigator/study teams, departments and other partners to ensure collaboration.
● Review study protocol for completeness, consistency, feasibility, compliance and referrals to expert groups.
● May serve as the single point of contact for the investigator/study team for projects by coordinating with cross-functional teams under the guidance of a Clinical Research Specialist. 
● Upon assignment of a clinical research study, lead efforts to review and understand the study protocol, goals and needs; consulting with CRSs as necessary. 
● Assist with the coordination of study documents. Documents may include, but are not limited to, protocol, informed consent form, recruitment materials, as required.
● Prepare investigator/study teams for ancillary reviews by leveraging support center experts and external collaborators.
● Participate in the feasibility review process for assigned projects.  Collaborate with the team to make modifications and enhancements to the process as necessary.
● Review study protocols for compliance with all applicable regulatory standards and policies related to clinical research.

(10%) Facilitate study activation
● Communicate study start-up activities necessary to meet study milestones in collaboration with investigators, study teams and support center experts. Advise on strategies for meeting the goals, including plans to address potential timing risks/gaps.
● Liaise with cross-functional teams to enable clinical study start-up.
● Assist with identifying issues before they become critical. Work through their resolution in collaboration with the Clinical Research Specialists, investigator/study teams and support center experts.
● Schedule, coordinate, and document regular project team meetings, as needed.
● Monitor project status. Ensure timely communication of study status to relevant stakeholders.

(10%) Education and advisement
● Advise researchers on the IRB approval and study activation processes.
● Facilitate connections between investigator/study teams and the appropriate experts including health data informatics, finance, biostatistics, research coordinators, biological sample management, subject recruitment, and various University committees that review and approve clinical research.
● Provide guidance to faculty and staff seeking to access CTSI services in the navigation of clinical research processes, through knowledge of federal and internationally recognized research regulations, research ethics, institutional policies and clinical research best practices.
● Assist investigator/study teams in ensuring efficiencies in research administration and execution. Facilitate sharing of research insights, best practices and education opportunities.

(15%) Support: Initiatives and process improvement
● Assist Clinical Research Specialists in identifying fundamental issues or systemic gaps pertaining to study activation at the University, and provide support with planning, coordinating and executing process improvement initiatives.
● Contribute to initiatives aiming at modifying practices and procedures to improve efficiency and quality.
● Participate in developing new activities, resources and guidance, including presentations, work groups and processes.
● Support the development and implementation of 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
● 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.

Keywords: Research Project Manager, Project Manager, Clinical Research Coordinator, CRC, Clinical Trial Associate, Program Manager, Clinical Research Specialist, RPM, CT

All required qualifications must be documented in application materials. 

Required Qualifications
● BA/BS with at least 5 years of experience or advanced degree with 3 years of experience; or a combination of education and experience to equal nine (9) years
● Experience must include 2 years’ experience with clinical and/or translational research.

Preferred Qualifications
● 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.
● Experience working in a Clinical Translational Science Award program.
● Experience working in managing multiple clinical studies with proven results in study activation.
● Experience with clinical research protocol review and development.
● Experience in developing a new program/service or expanding an existing program/service.