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A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
A new model for the clinical trials enterprise includes an organizational structure of local Clinical Trial Support Units (CTSUs), central infrastructure, and governance oversight. The CTSUs are trans-departmental and thematically aligned based on research foci. CTSUs are the local units that provide comprehensive pre- and post-award support to study teams, offering high-quality, efficient service in support of a mix of clinical trials. They will provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty.
In collaboration with the CTSU Medical Directors and Lead CTSU Administrator, this position is responsible for developing, enhancing and managing the clinical trials serviced by the CTSU. Supervise the day-to-day research and protocol specific activities associated with the CTSU as it pertains to participation in clinical research studies. Supervise study coordinators. Establish training standards and ensure that staff meets those standards. Participate in assessing the feasibility of new studies. Work with the CTSU Medical Directors and Lead Administrator to ensure appropriate monitoring of individual studies and all CTSU clinical trials in aggregate. Ensure that new studies are initiated appropriately and monitor the performance and progress of ongoing studies. Working with the CTSU business analysts and regulatory specialists coordinate IRB submissions, patient recruitment and enrichment, data collection, safety reporting, drug accountability, and record retention. Coordinate with other CTSUs as appropriate. Coordinate with ancillary units are appropriate (i.e. IDS, MCRU)
Review and supervise activities performed by study coordinators involved in study conduct and ensure that activities are performed in accordance with Good Clinical Practice standards, UM, School, and Departmental policies and procedures, and any other applicable requirements.
The Clinical Research Project Manager may have up to 50% project work performing study coordinator activities. They will be available to assist study teams with study coordinator activities such as screening, consenting and enrolling subjects, collecting and managing patient and laboratory data, data entry, IRB application preparation, and regulatory management. Additionally, the CRPM will manage audits and monitor visits, as well as other duties as needed. This position could include travel to off-site locations and/or subject home visits.
Plan and coordinate staffing needs based on current and future workload requirements. Screen, interview and hire study coordinators and other research staff in conjunction with faculty and administrative input. Manage the onboarding process for coordinators and clinical research staff. Plan and coordinate orientation and ongoing training for study coordinators and other research staff. Ensure that current training records and required certifications are maintained. Coordinate and assign study coordinators and other research staff to individual studies and research related activities. Supervise study coordinators and other research staff and perform various personnel actions including, but not limited to, hiring, performance planning and evaluation, scheduling and work assignments. Conduct regular meetings with study coordinators and other research staff. Ensure that staff is kept abreast of institutional, departmental and institutional activities, goals, and policies and procedures.
Along with the Lead Administrator and the Medical Directors participate in the CTSU feasibility review for new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies. Assist with the review and ensure appropriate planning and coordination prior to the approval and initiation of new protocols; including working with other node personnel on the accurate and timely development of the billing calendar based on the schedule of events and protocol. Assist in budget/contract negotiations with sponsors. Assist with the assembly and submission of billing calendars and IRB as needed.
Monitor the status of start-up timelines for new studies including IRB approval and contract execution. Monitor the progress of ongoing studies including enrollment, data collection, and closeout. Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory issues. Facilitate efforts to address issues. Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions. Participate in audits conducted by sponsors, and regulatory authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems in research practice are identified.
In concert with the Medical Directors and the Administrator ensure up-to-date standard operating procedures (SOP), templates, provisions, etc., that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs. Serve as a 'super user' for the CTMS and MI CHART for research purposes. Keep abreast of upgrades and work with research office staff to implement process changes reflecting those changes. Manage mail groups for the dissemination of information. Other duties and responsibilities as assigned.
- Bachelor's degree or equivalent
- Mastery of previous positions required.
- Ability to work independently or in a team environment.
- 5 or more years' clinical research experience at a progressively involved level.
- Master's degree or equivalent preferred.
- ACRP or SoCRA Certification desirable.
Monday - Friday, Work hours vary depending on need.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.