How to Apply
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.
The Clinical Research Project Manager - Data (CRPM-Data) position will provide clinical trial coordination for program studies supported by the Oncology Clinical Trials Support Unit (O-CTSU) and lead the day to day operations on project implementation and management. The CRPM-Data will also provide functional and administrative supervision for a team of O-CTSU Clinical Research Coordinators; and will take direction from and work closely with the Administrative Manager/Portfolio Manager and O-CTSU Leadership.
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.
Assist Administrative/Portfolio Manager (APM) in clinic research/subjects coordinators (CRCs) and program oversight.
Lead research activities in clinical research for assigned programs.
- Functional supervision of clinical research/subjects coordinators (CRS):
- Assist with oversight of the quality of clinical trial coordination in the data setting.
- Train and educate on aspects of clinical research.
- Assess workload and distributes studies to CRCs as needed.
- Facilitate resolution of study related data issues.
- Maintain data coverage including fielding and approving time off requests.
- Provide administrative support including effort estimates, study startup, and Clinical Research Team (CRT) oversight.
- Provide feedback to APM on team performance.
- Develop case report forms for investigator initiated trials and participate in ongoing quality assessments.
- Administrative supervision of clinical CRCs as assigned.
- Serve as a data study coordinator on program studies.
- Provide data management and study coordination on multiple projects that support faculty members and the research team in the conduct of clinical research projects.
- Enter required data into clinical trial management system (CTMS) in a timely fashion to meet department needs.
- Works closely with staff and biostatistician core to ensure study compliance and assists in the analysis of data.
- Register eligible patients to CTMS and with Sponsor after confirmation of eligibility.
- Accurately and precisely abstract data on patients from various sources to comply with requirements of sponsor and protocol.
- Meet requirements for appropriately reporting study deviations, adverse events, serious adverse events and preparation of Data Safety and Monitoring reports.
- Insures compliance with SPGs, GCPs, FDA, ICH, and IRB regulations/guidelines/policies.
- Collaborate with APM and O-CTSU clinical leader to problem solve and establish best practices.
- Serve as a link with the Clinical Mid-Level providers and clinical nurses in team programs.
- Exchange information on relevant clinical issues that have a bearing on research and reverse.
- Serve as a link with the Ravitz/Infusion/Inpatient floor on program studies.
- Serves as a leader for O-CTSU at feasibility meetings, pre-SIV, logistic meetings, SIV meetings, and CRT meetings as needed.
- Bachelors's degree with demonstrated commitment to continued professional development.
- 2+ years Oncology research experience.
- 4+ years Clinical Research experience.
- ACRP, SoCRA Certification.
- Demonstrated success in leadership endeavors such as project management, functional and/or administrative staff supervision, leadership of a team or a program.
- Demonstrated high level of competency in roles that will fall under CRPM title.
- Demonstrated emphasis on teamwork.
- Excellent interpersonal and conflict resolution skills, diplomacy.
- Demonstrated fully engaged in and actively contributing to team and Michigan Medicine mission and vision.
- Demonstrated taking initiative in process improvement and functions in self-directed manner.
- Demonstrated fully engaged in and actively contributing to team/O-CTSU/Cancer Center mission and vision.
- Experience as a supervisor/manager.
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening 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.