Clinical Research Coord Inter

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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 Mary H Weiser Food Allergy Center has an opening for a Clinical Research Coordinator to manage a clinical trial involving COVID-19 vaccinations.

This clinical research coordinator (CRC) position will provide study coordination for multiple clinical research studies ranging from moderate to complex. Coordinator experience and mastery of all job duties from the CRC Intermediate position on the Michigan Medicine CRC Career Ladder   is required.

The individual in this position will demonstrate 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, from multiple funding sources including industry, foundations, and government.

The individual will contribute 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. They will be involved in assembling data from clinical trials and producing graphical representations to aid the analysis and presentation of research.

This CRC position requires an extensive background and experience that ensures competency and will require investments in their ongoing continuing education and professional development. We expect this individual to be involved In a minimum of three simultaneous trials in different subject areas and varied sponsors.

What You’ll Do

Day-to-day conduct of clinical trial activities in food allergy studies, a birth cohort and COVID-19 vaccination research. Responsibilities will include screening, consent, and evaluation of subjects, maintenance of accurate source documentation, electronic data entry, and management of the study schedule. The CRC will also be responsible for overseeing communications with the IRB and funder, central IRB and CRO. The candidate will be responsible for working with investigators and other members of the research team as well as University of Michigan Core units and labs to assure efficient and accurate study conduct and record keeping.  The CRC should be able to extract and plot data in a manner that allows evaluation by the investigators. This work may also include UM institutional review board interactions.

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*

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

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operation s (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Duties to include:

Screening, consent, and evaluation of subjects.

Prepare reports and collate data for sponsors in conjunction with investigators.

Maintenance of accurate source documentation, electronic data-entry, and management of the study schedule.

Work with all members of the research team and University of Michigan Research Units to assure efficient and accurate study conduct and record-keeping.

Oversee and monitor institutional review board interactions.

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 certification must be completed or passed etc. before the 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.)
• Experience working with adults and children
• Excellent interpersonal, oral, and written communication skills with attention to detail
• Demonstrated ability to prioritize and problem solve effectively and efficiently and work well with time constraints and deadline
• Demonstrated accountability and dependability with independent work
• Prior proficiency in basic office software applications such as Microsoft Excel, Work, Outlook, etc.
• Previous experience with institutional review board interaction, including study protocol management.
• Prior proficiency in research data entry systems including REDCap.
• Minimum 2 years of directly related experience in clinical research and clinical trials, is desired.

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.