The Clinical Research Coordinator will work with the PI and Program Manager to achieve operational objectives at a high quality level. Duties include participation in protocol evaluation, managing IRB submission and renewals, budget/billing calendar, screening/enrollment, trial execution, compliance, and adverse event reporting. Additional participation in Network activities will include regular conference calls, interaction with other Michigan centers and periodic meetings.
- Participate in conduct of externally funded, multi-center Critical Care clinical trials, including cutting edge COVID trials within the NHLBI PETAL (Prevention and Early Treatment of Acute Lung Injury) and ACTT networks.
- Engagement and ownership through the clinical trials process, including the initial regulatory phase through execution and closeout
- Contribute as a key member of a multidisciplinary Critical Care collaboration
- Support regulatory efforts and facilitate research projects for faculty and fellows in the Division of Acute Care Surgery.
- Trial conduct, including:
- Screening patients for eligibility
- Obtaining informed consent
- Abstracting patient data from electronic medical records; data quality assurance
- Processing and storage of blood samples including the use of a centrifuge;
- Maintaining subject study files
- Maintain regulatory study files
- Electronic data entry of subject report form
- Communicate with the Institutional Review Boards at the University of Michigan Medical School for submission of all new applications and annual renewals, amendments etc.
- SAE and AE reporting
- Research enrollment reporting with the UM Clinical Research Calendar Review and Analysis Office.
- Other duties as assigned.
- A commitment to excellence in clinical research is essential
- Minimum of two to three year's experience in clinical research and IRB applications and amendments.
- Proficient in Microsoft Word and Excel.
- Excellent interpersonal and communication skills and ability to establish rapport with patients, patient families, and multiple clinicians.
- Highly organized, attentive to details, with ability to work independently in a fast-paced clinical setting (Intensive Care Unit).
- Must be proficient in oral and written English.
- Familiarity with UM Health System electronic medical record systems preferred.
- Candidate must be dynamic and self-motivated, looking to work in conjunction with the Acute and Critical Care Trials Support Unit. This position will be part of a team working to establish 24/7 coverage of trials within the ACCTN. Flexible scheduling is a requirement to accomplish this goal
- The strong candidate will demonstrate commitment to excellence in clinical research, adhering to appropriate standards and guidelines and exceptional organizational skills. As a member of a high-functioning team, the individual must have the ability to make independent decisions, free from immediate direction, within the scope of their responsibilities. Candidate must be able to work in Acute Care environment and with federally funded Intensive Care Unit clinical trials.
- SOCRA certification. The PI will support maintenance of certification.
- Prior experience with laboratory administration and finance.
- Knowledge of and experience with UMHS basic research, ULAM and UCUCA policies and procedures.
This position will be part of a team working to establish 24/7 coverage of trials within the ACCTN. Flexible scheduling is a requirement to accomplish this goal.
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.