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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

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-Intermediate position on the Michigan Medicine CRC Career Ladder is required, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management and participating in training and development of junior clinical research professionals. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position 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, develop, evaluate, guide, mentor, and support.

This position will oversee and guide Wilson Disease Registry Development, Clinical Trials with Gene replacement therapies, Clinical Trials with Gene Correction therapies and small molecule therapies for Wilson disease and immune modulation studies for other liver diseases. Will have the ability to orchestrate both observational and interventional studies is essential with multiple cross disciplines and worldwide collaborators and study sites where Michigan is the lead study site on some studies. The ideal candidate would demonstrate advanced skills and knowledge of Wilson Disease and experience in gene therapy trials along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies and study types including but not limited to observational cohort studies, immune modulation studies, viral vector gene therapy, gene editing and novel copper reduction therapies. Exceptional interpersonal skills establishing long term patient relationships is essential for this position. The Senior Study Coordinator will need the skills to develop new processes, procedures, tools, and training to enhance clinical research activities across all aspects of these novel studies.

Why Join Michigan Medicine?

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*

Contribute to the development of process and tools in 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

The successful applicant would be responsible for a variety of duties including but not limited to:

1. Clinical Coordinator Responsibilities: Study Screening, develop and implement novel lead in study screening techniques such as offering sibling phenotype and
   genotype screening as part of lead in interventional study design to identify rare disease new diagnosis study subjects. Matrix with investigators, sponsors, patient
   advocacy groups and perform quality checks of others work. Start up study initiation coordination, develop and apply critical thinking, innovative and creative
   problem solving across a wide variety of clinical trial designs including novel gene therapy, gene correction, registry and small molecule therapeutic drug designs.
   Capable of conducting and supervising all startup, active implementation, and closeout activities. Develop standard procedures for novel clinical trial designs and
   compounds.
2. Data Coordinator Responsibilities: Perform quality checks and mentor study participants, study management, talking with study subjects, CRO, and sponsors,
   Oversee EDC management, coordinating visits, PI and co-investigator communication. Develop new processes, implement novel gene correction, gene therapy,
   international small drug and observational studies. Contributes to the development of processes and tools to support the non-GCP and GCP-related activities
   associated with study execution. Performs complex study procedures with accuracy including working with investigational pharmacy on complex biologics.
   Develop processes and tools to address subject concerns compassionately. Knowledge of the elements and development of an effective corrective and preventive
   action plan (CAPA) Develops processes, tools, and training to capture data in accordance with ALCOA-C principles. Demonstrates the ability to create and
   manage database and repository and innovate in their function to be on the cutting edge of clinical trial design and implementation.
3. Regulatory Coordinator Responsibilities: Develop new processes, skills, and techniques to enhance patient clinical trial and registry design, enrollment, and
   management. Develop processes and tools to prepare for regulatory audits and coordinate conduction with sponsors, principal investigator and regulators.
   Perform quality checks on work of others at this and other clinical trial sites. Monitor site compliance with subject safety reporting, escalate issues to PI, IRB,
   co-investigators and sponsor, and contributes to the development of tools and processes to enhance subject safety during the conduct of all diverse clinical studies. Oversees regulatory documentation for quality assurance. Contributes to the development of processes and tools to enhance site compliance with the requirements necessary for the safe and effective development of investigational products. Audits quality of others work as well as critically reviews and critiques
   own work.
4. Administrative Responsibilities: Coordinate research with international study sites for example having patients treated at Michigan Medicine for gene therapy
   scanned in Aarhus Denmark for 65Cu PET studies to independently assess gene therapy efficacy. Runs study meetings. Matrixes and liaises with other clinical trial
   specialists within the GI Division, Department of Neurology, Pediatrics and others as appropriate. Reviews study forms, databases, regulatory files, and all study
   related work for completion and accuracy; Develop standard operating procedures, work-aids and other guidance for study group. Reviews questions, develops
   answers, solves problems and gets answers to study related questions. Serves as lead study site for other study sites and helps sponsors and CROs
   develop, mentor, train and oversee SOPs.
5. Training: Mentoring, Supervision, training and coordination of research trainees including but not limited students, residents and fellows. Maintains
   Certifications. Oversees research professionals.
6. Committee service, local and national. Wilson Disease Center of Excellence steering committee, as well as Advisory Committee to Wilson Disease Association,
   as well as other institutional clinical trial study committees as needed. Coordinate and perform quality checks with international Wilson Disease Association patient
   groups.

Supervision Received: This position reports directly to Principal Investigator.

Supervision Exercised: Could provide functional supervision (likely in limited capacity such as training) of staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, or CRC Intermediate.

Required Qualifications*

Clinical Research Coordinator Senior:

• CRC Governance Committee review and approval
• Bachelors 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 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Clinical Research Coordinator Intermediate:

• 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 SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Desired Qualifications*

Clinical Research Coordinator Senior:

• 9+ years of direct related experience

Clinical Research Coordinator Intermediate:

• 6+ years of direct related experience

Work Schedule

This is a full-time 40 hour/week position.

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.

Underfill Statement

This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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.