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How to Apply

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.

Job Summary

We are seeking a responsible, motivated, individual who will independently provide study coordination for simple and moderately complex clinical research studies.  As a member of a coordination team, this clinical research coordinator (CRC) position may help support a portfolio of projects with varying levels of 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.  This position has a term limitation of 2 years, with an option to extend if funds are available.

Mission Statement

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.

Responsibilities*

Characteristic Duties and Responsibilities:

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

Scientific Concepts and Research DesignEthical Participant Safety ConsiderationsInvestigational Products Development and RegulationClinical Study Operations (GCPs)Study and Site ManagementData Management and InformaticsLeadership and ProfessionalismCommunication and Teamwork

Responsibilities:

Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to:Regulatory submissions, creation/maintenance of regulatory bindersSubject screening, consenting, enrollment, management of study recordsData collection, entry, sharing, storage, management, query resolutionCreate and complete case report forms, source documentation, study documents and toolsDatabase/survey development in various electronic platforms (REDCap, Qualtrics)Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeoutAssess studies for execution and troubleshoot potential implementation issues.Provide cross-coverage on projectsPerforms study procedures with accuracyDemonstrates ability to triage complex study concerns appropriatelyDemonstrates ability to manage increasing levels of protocol complexity and/or volume efficientlyContributes to the development of processes and tools to capture data in accordance with ALCOA-C principlesResolves complicated queriesDemonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processesMonitors 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 studyProvides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelinesProvide other administrative support for study activity including management of subject reimbursement and paymentsParticipates in trainings specifically for maintaining certification as a Clinical Research Professional

Required Qualifications*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 SoCRA or ACRP prior to applying.)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 for qualifying experience prior to applying.)Excellent organizational skills and attention to detail.Superb interpersonal skills ? comfortable speaking with healthcare providers, research sponsors, and patients. Ability to communicate effectively and professionally in both verbal and written form.Ability to work independently but also within a team. Ability to prioritize multiple tasks and meet deadlines are a must.  Desired Qualifications*6+ years of direct related experienceExcellent communication skillsAbility to foresee needs of investigators/study teams and respond accordinglyPossess critical thinking skillsAbility to triage complex study concerns appropriatelyWork Schedule

This is a full-time regular position.  Monday-Friday:  8am-4:30pm; On-site work required.  Travel to satellite clinics may be required.

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.

Additional Information

This is a term-limited appointment for 2 years, with an option to extend if funds are available. 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 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.

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/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.