Clinical Research Coord Inter

Job Title

Clinical Research Coordinator

Job Summary

The REMEDY team at the University of Michigan (UM) manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM, industries, and Universities. We specialize in multi-center, including international, device trials as well as outcomes research, drug trials, and investigator-initiated studies. As we continue to expand our portfolio, we are looking for detail orientated, highly motivated, compassionate individuals to join our team.

Responsibilities*

Expert level knowledge, skills, and abilities within all 8 competency domains is expected

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

30% - Clinical Coordinator Responsibilities

• Performs study procedures with accuracy
• Triages complex study concerns appropriately
• Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits
• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
• Leads aortic clinical trials under supervision of Clinical Trial Lead and Clinical Research Manager.

25% - Data Coordinator Responsibilities

• Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles
• Creates CRFs, study documents, and tools
• Resolves complicated queries

25% - Regulatory Coordinator Responsibilities

• Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
• Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes

15% - Administrative Responsibilities

• Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines
• Provides other administrative support for study activity including management of subject reimbursement and payments
• Oversees aortic clinical research coordinator(s)
• Supports study team members on a range of communication and teamwork best practices

5% - Training

• Participates in trainings specifically for maintaining certification as a Clinical Research Professional

Supervision Received: This position reports directly to the Clinical Trial Lead for the Department of Cardiac Surgery.

Supervision Exercised: None.

Required Qualifications*

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP)
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

Work Schedule

Hours/Week: 40 hours

Shift/Hours/Days: Days, occasional evening and weekends, on call

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 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.