"Clinical Research Coord Inter"

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 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.

This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

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.

Hours/Week: 40 hours

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