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University of Michigan Clinical Research Coord Intermed-Hybrid/Term Limited in Ann Arbor, Michigan

Clinical Research Coord Intermed-Hybrid/Term Limited

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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.

Summary

The Department of Otolaryngology-Head and Neck Surgery is seeking a Clinical Research Coordinator to join a dynamic, highly impactful pediatric, clinical translational NIH funded team. This opportunity allows wonderful and highly rewarding patient and family interactions, where you will be involved with a clinical trial of a novel medical device, developed at the University of Michigan as a therapy for children with hypotonia and obstructive sleep apnea. Our positive, energetic team is composed of Otolaryngology-Head and Neck Surgery, Sleep Medicine, Biomedical Engineering, and Neurology and has been recognized by the Medical School as a research group of excellence. The successful applicant will have interest in engaging in our ongoing NIH funded clinical trial (NCT05527652). In this role, and with guidance from faculty and research personnel, day to day responsibilities will include, but are not limited to screening and enrollment of families for an interventional trial, meeting families for study visits, assist with assessments and data collection, conducting telephone visits, assist with regulatory as well as DSMB reports, and assist in preparing NIH progress reports and other summary materials. Both in-person and remote work is expected along with some after-hours work to support participant activities when needed, thus flexibility is required. There are also opportunities to be involved in additional clinical studies and interact with other collaborative institutions through NHLBI and NIH. The successful candidate will have career development opportunities through the University of Michigan Institute for Clinical and Health Research program and will have access to multiple seminar series including the Biological Rhythms and Sleep Seminar as well as other optional lectures series.

CRC STATEMENT:

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 theMichigan Medicine CRC Career Ladder (https://research.medicine.umich.edu/our-units/clinical-trials-support-office/clinical-research-coordinator-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 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.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities though excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, national 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*

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

In this role, and with guidance from faculty and research personnel, day to day responsibilities will include, but are not limited to:

  • Screening and enrollment of families for an interventional trial

  • Meeting families for study visits,

  • Assist with assessments and data collection.

  • Conducting telephone visits

  • Assist with regulatory as well as DSMB reports.

  • Assist in preparing NIH progress reports and other summary materials.

Supervision Received:

This position reports directly tothe faculty Principal Investigator.

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.

Desired Qualifications*

  • 6+ years of direct related experience

  • Experience working in clinical research or patient settings is a plus.

Work Schedule

This position is eligible for a hybrid schedule (work remotely and onsite) depending on the needs of the department. Both in-person and remote work is expected along with some after-hours work to support participant activities when needed, thus flexibility is required.

Additional Information

This is a term-limited position through 8/31/26 with potential for continuation on future projects. 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.

Job Detail

Job Opening ID

247674

Working Title

Clinical Research Coord Intermed-Hybrid/Term Limited

Job Title

Clinical Research Coord Inter

Work Location

Ann Arbor Campus

Ann Arbor, MI

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Medical School

Department

MM Otolaryngology - HNS

Posting Begin/End Date

5/09/2024 - 6/03/2024

Career Interest

Research

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