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.
We are seeking an experienced, independent, positive, organized individual with excellent record-keeping and communication skills as a Clinical Research Coordinator Intermediate at the University of Michigan. The job will involve working with a clinical research team and program manager to maintain a large, longitudinal cohort of skin and systemic autoimmune diseases and to launch and coordinate translational and clinical research trials.
This position will involve working with patients diagnosed with autoimmune disease.
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. 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.
Contribution to the development of process and tools in 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
- Coordinate the overall conduct of multiple clinical research studies from study start-up through close-out, ensuring activities are completed in accordance with study protocols, applicable regulations, and institutional requirements.
- Manage study start-up and initiation activities, including preparation and submission of initial IRB applications, informed consent documents, and other required study materials.
- Screen and enroll eligible study participants and obtain informed consent in accordance with approved protocols and regulatory requirements.
- Coordinate and conduct participant visits, study assessments, and other research-related activities as required by study protocols.
- Coordinate the collection, processing, storage, and shipment of study samples in accordance with protocol and laboratory requirements.
- Process participant payments and maintain accurate documentation related to study compensation.
- Prepare for and support study closeout activities, ensuring required documentation and study materials are complete and properly maintained.
- Develop and maintain study-specific resources, tools, and standard operating procedures (SOPs) as needed.
- Manage study data, including data collection, entry, review, and reconciliation, and ensure timely resolution of data queries.
- Serve as the primary point of contact for study participants, investigators, study monitors, and other research stakeholders.
- Maintain accurate and complete study records and documentation throughout the duration of each study.
- Perform other administrative and research-related duties as assigned.
The position will interface with clinical research teams in Dermatology and Rheumatology. Opportunities for growth include expansion of clinical trial work, supervision of junior coordinators and advancement through the Clinical Research Coordinator Career Ladder.
Supervision Received: This position reports directly to Faculty Principal Investigator, Dr. J. Michelle Kahlenberg
Supervision Exercised: No supervison exercised at this time beyond helping students.
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
- 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
