How to Apply
A cover letter is required to be considered 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 the position.
Job Summary
The Clinical Research Coordinator is a vital member of the Transplant Research team who will help ensure that clinical research studies conducted at the Transplant Center are initiated and executed with the utmost quality, care, and compliance. To be successful in the position, the candidate must demonstrate exceptional organizational and problem solving skills and possess uncompromising integrity. Applicants who desire a patient focused, team oriented, medically complex, scientifically interesting, intellectually stimulating, and fast paced work environment are encouraged to apply.
Why Join Michigan Medicine?
Being part of something greater, of serving a larger mission of discovery and care ? that's the heart of what drives people to work at Michigan. In some way, great or small, every person here helps to advance this world-class institution. It's adding a purpose to your profession. Work at Michigan and become a victor for the greater good.
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
Responsibilities*
The Clinical Research Coordinator (CRC) will be responsible for the meticulous conduct of both interventional and observational clinical research studies, including pharmaceutical, industry sponsored trials, as well as investigator-initiated research across multiple departments in Michigan Medicine. The CRC will work with patients in both the inpatient and outpatient settings, including both recipients and donors of solid organ transplants. The CRC must be able to simultaneously integrate the workflow for multiple studies and will serve as a resource and contact person for active protocols. The CRC will be expected to facilitate communications between investigators, clinical staff, sponsors, contract research organizations, regulatory personnel, research patients, research support units, and study team members. This position also requires timely data entry, laboratory processing, accurate documentation, and the ability to work well within a team.
Experience as part of a team with all 8 competency domains is expected.
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
25% Clinical Coordinator Responsibilities (ex. 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.)
- 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
25% Data Coordinator Responsibilities (ex. Completes simple to moderately complex data collection during study visits; Resolves simple data queries)
- 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.
25% 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.
15% 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.)
10% 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.
*Responsibilities will vary depending on unit specific needs. Some units/teams may have unique needs for proportionate focus on clinical, data, regulatory, or other needs. The Clinical Research Technician position will most likely support project implementation needs as part of a team.
Required Qualifications*
- Associate degree in Health Science or an equivalent combination of related education and experience is necessary;
- Minimum 1 year of directly related experience in clinical research and clinical trials is necessary; Please review SoCRA's Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
- Previous Prior experience writing and maintaining IRB submissions, including initial applications, continuing reviews, amendments, and adverse events;
- Prior experience collecting and maintaining regulatory documentation;
- Proficiency in working with electronic medical records;
- Knowledge of and experience with ethical and regulatory aspects of medical research and appropriate conduct of clinical trials, including The Code of Federal Regulations (CFR) and Good Clinical Practice (GCP);
- Ability to create source documents, to track protocol-required data points;
- Ability to communicate professionally and interact effectively with patients, faculty, staff, and others; team-work is a critical component of this position;
- Ability to train others in protocol-required tasks. This could include other coordinators, nursing staff, MAs, etc;
- Ability to work independently, think critically, prioritize, and exercise good judgement;
- Proficiency with computers, specifically MS Word and Excel;
- Desire to work in a fast paced, patient oriented environment to further scientific knowledge;
- Positive attitude and desire to continually learn and grow professionally;
- Availability to work some evenings, nights, weekends, and holidays to participate in the shared coverage of the on-call schedule necessitated by transplant organ availability; living within a 30-mile radius of the University of Michigan Hospital;
- Exceptional customer service abilities.
Desired Qualifications*
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.
- An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
- Three or more years of experience in medical research and clinical trial coordination;
- Experience with both pharmaceutical clinical trials and investigator initiated protocols;
- Demonstrated success working on multi-site research as both coordinating center and participating site;
- Knowledge of Michigan Medicine policies and practice;
- Familiarity with solid organ transplant patient care and terminology;
- Familiarity with infectious disease patient care and terminology;
- Experience with REDCap, iMedidata, or other data entry platforms.
Work Schedule
- Normal work schedule is 8 a.m. to 4:30 p.m., Monday through Friday;
- Participation in on-call schedule is required and additional pay is provided for one or more shifts per month that may include:
- On-call work primarily conducted remotely and requires presence at the hospital when transplants occur outside of business hours and study requires in-person procedures.
Work Locations
- Coordinator work is currently being conducted in a hybrid model with a mixture of remote and on-site work as needed to perform the requirements of the role while maintaining high quality and service level to principal investigators and patients
- Post-pandemic work will resume at the discretion of the University of Michigan Office of Research; primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at Taubman Center, the Adult Hospitals, Mott Hospital, and other locations on the main medical campus as appropriate.
Modes of Work
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.
Background Screening
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.
Application Deadline
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 Statement
The University of Michigan is an equal employment opportunity employer.