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.
This is the entry level position on the Michigan Medicine CRC Career Ladder. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
Characteristic Duties and Responsibilities:
Knowledge of all 8 competency domains is expected:
Performs simple study procedures with accuracy.
Performs clerical duties, including, but not limited to, mailing and filing correspondence, calling patients and obtaining medical records.
Performs moderately complex study procedures with accuracy.
Triages simple subject concerns and issues appropriately.
Assesses studies for execution and troubleshoots potential implementation issues.
Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
Completes simple to moderately complex data collection during study visits.
May work with CTSUs to reconcile financial accounts for study participants.
Assists with local quality control efforts.
May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment
May assist research coordinator in conduct of Site Initiation Visit (SIV); attends SIV
May assist in and attends monitor visits and or audits.
Ability to assist with regulatory aspect of clinical trial management.
Prepare study procedure kits, shippers, CRFs, and requisition forms.
Ability to work independently or as a member of a team
Exceptional organizational and computer skills in Microsoft software applications.
Ability to work with minimal supervision while maintaining productivity standards
Demonstrated problem solving and conflict resolution skills.
Ability to multi-task, work well under time constraints and meet deadlines.
Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.
Perform other related duties as assigned.
Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants
May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.
May obtain the CTN number for eResearch applications.
Completes simple to moderately complex CRFs.
Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
May assist in CRF development for Investigator Initiated trials.
Regulatory Coordinator Responsibilities (ex. - Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)
May complete new eResearch applications.
May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
May gather participant approval via informed consent.
Prepares and participates in internal and external audits.
Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.
Administrative Responsibilities (ex. - Provide other administrative support for study activity including scanning, filing, etc. of research documents as well as preparing, processing, and shipping biospecimens.)
Demonstrates understanding of the clinical research objectives associated with the program.
May communicate with study participants such as sending study correspondence via mail or email.
May schedule subjects for research visits and FU appointments.
May check study calendar for completion of study procedures.
May manage study supply inventory.
May utilize documents and systems to track recruitment and retention of participants.
May complete and activate postings (advertisements, flyers, etc.) independently.
May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)
Training (ex. - Participates in training opportunities on Good Clinical Practices (GCP))
All training requirements of previous level.
PEERRS, HIPAA, CITI GCP
Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
Willing to learn and use available technology and systems to accomplish job requirements.
Understands the disease process per program.
Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others.
Other duties as assigned
High school diploma or GED is necessary.
Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.
An understanding of medical terminology
Minimum 1 year of directly related experience in clinical research and clinical trials is necessary
Experience in a large complex health care setting
Ability to effectively communicate with staff and faculty of all levels
Knowledge of university policies and procedures is desirable.
Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available.
Clinical experience with respiratory patients is highly desired.
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your very first day
- 2:1 Match on retirement savings
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Hybrid (at least 2 days onsite). Time varies depending on research needs (8:00 AM - 4:30 PM; 7:00 AM - 3:30 PM; 10:00 AM - 6:30 PM).
Supervision Received: This position receives direct supervision and reports directly to CRC-Project Manager.
Supervision Exercised: None
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
This is a term-limited appointment. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.
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 any time after the minimum posting period has ended.
The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.
