Job Summary

As an integral member of the research team, the Clinical Research Coordinator Associate (CRC) will help ensure that clinical
research studies supported by the University of Michigan Kellogg Clinical Research Center (KCRC) are initiated and executed in
the highest quality and compliant manner. In order to succeed, the applicant must possess exceptional organizational skills,
uncompromising integrity, a love of people, and a strong willingness to learn new skills.

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.

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*

COMMUNICATIONS: The CRC is expected to facilitate communications between sponsors and contract research organizations, research volunteers, investigators, regulatory personnel, and other key contributors such as the University of Michigan Clinical Trial Support Unit (CTSU). The communications will include but are not limited to scheduling appointments, meeting with investigators, interfacing with the regulatory and financial authorities, working closely with study monitors, and resolving issues that invariably arise.

DATA: The CRC will help carry out data acquisition through various testing modalities (e.g. visual acuity, refractions, intraocular pressure, etc.), inputting data into case report forms (CRFs), maintaining studies in the OnCore clinical trial management system, and resolving queries.

REGULATORY COMPLIANCE: Employees of the KCRC follow all local, state, and federal regulations regarding clinical research in addition to Good Clinical Practice and protocol specific guidelines. The CRC is expected to actively support an environment of strict regulatory compliance.

RECRUITMENT: The CRC will work with the investigators in order to recruit and retain study participants.

PROTOCOL SPECIFIC NEEDS: In addition to the broad technical skills needed in nearly every ophthalmic clinical study (e.g. visual acuity, refraction, intraocular pressure, etc.), each study often has unique needs. The CRC is expected to possess a willingness to learn protocol specific requirements.

OTHER: Clinical research regulations and best practices are frequently changing. The CRC is expected to incorporate these changes into the work flow as they occur. In addition, the CRT will need to become proficient with phlebotomy and acquire various certifications pertinent to the position.

Required Qualifications*

Associate:

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 2 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.

Technician:

Associate degree in Health Science or an equivalent combination of related education and experience.
ONE of the following:
- Minimum 1 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.
- An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
- Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

All Titles:

Knowledge of general clinical research operations and regulations or a capacity to learn quickly
Willingness to achieve professional certification such as SOCRA or equivalent
Committed to prioritizing the welfare of the research volunteer
Exceptional organizational skills
Uncompromising integrity
Capacity to learn new skills as the positional needs change
Ability to work both independently and as part of a team
Experience with computer keyboards and applicable software (e.g. MS Word, Excel, Power Point, Outlook or equivalent)

Desired Qualifications*

Bachelor's degree in Health Science or an equivalent combination of related education and experience
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable
At least one year of directly related experience in clinical research and clinical trials
Experience as an ophthalmic technician or equivalent (at least 2 years)
Experience with the MiChart (Epic) electronic health record (EHR) system
Experience with the OnCore clinical trial management system (CTMS)

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 a lower classification depending on the qualifications of the selected candidate.

Additional Information

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.