Clinical Research Coord Assoc

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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

This position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the Clinical Research Technician position is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. 

This position will provide study coordination for multiple clinical research studies, primary of which are two related studies that fund the position.  All the studies are non-interventional, non-treatment, and require either proficiency with, or the willingness to learn, IRB documentation and regulatory management.  Experience with EHR data extraction and RedCap management, and IRB documentation are all preferred, but not required as we can provide training.  Key behavioral competency descriptors include demonstrate, implement, execute, and use.

We welcome all applicants and encourage those who are intermediary steps towards medical school.  For all applicants, we encourage and support independent research projects leading to authorship, to advance their careers. 

Coordinator experience and mastery of all job duties from the Clinical Research Technician position is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. They also know where and how to identify appropriate resources and support and can discern when to escalate issues needing additional intervention. This position can perform most tasks independently and perform quality checks of their work.

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*

Independent 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

Essential:

30% - Clinical Coordinator Responsibilities ex. ? Performs non-GCP related study management activities; Performs study procedures with minimal supervision; Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits; Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)

  • Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures. 
  • Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
  • Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
  • Demonstrates accurate implementation of protocol procedures.
  • Explains and performs study non-GCP related study management activities.
  • Performs study procedures with minimal supervision.
  • Triages simple subject concerns and issues appropriately.
  • Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.
  • Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
  • Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
  • Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.

Data Coordinator Responsibilities ex. Demonstrates the ability to document data in accordance     with ALCOA-C principles; Completes complex data collection during study visits; Demonstrates ability to resolve data queries

  • Demonstrates the ability to document data in accordance with ALCOA-C principles.
  • Explains how to utilize information from the EMR and study databases.
  • Completes complex data collection during study visits.
  • Demonstrates ability to resolve data queries

Regulatory Coordinator Responsibilities ex. ? Form completion and reporting to external governing bodies such as the FDA; Demonstrating an understanding of the elements of subject safety, related documentation, and reporting; Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks

  • Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
  • Explains proper documentation techniques as outlined in the ICH-GCP guidelines.
  • Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
  • Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
  • Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
  • Collaborates with MIAP for INDs and IDEs.
  • Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
  • Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
  • Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
  • Maintenance of updated regulatory documentation.
  • Explain the investigational products development process and identify key regulations to control these processes

Administrative Responsibilities ex. Provide other administrative support for study activity including management of subject reimbursement and payments

  • May assist with creating posters, abstracts, and articles
  • Participates in regular study meetings. Properly completes payment forms and pays participants accordingly

Training ex. Participates in trainings specifically for certification as a Clinical Research Professional

  • All training requirements of previous level.
  • PEERRS, HIPAA, CITI GCP
  • eRPM` Regulatory training
  • Attends and participates in all training assigned to this level.

Responsibilities will vary depending on unit specific needs. Some units/teams may have unique needs for proportionate focus on clinical, data, regulatory, or other needs. The CRC Associate position will support project implementation needs individually or as part of a team.

Supervision Received : This position should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator

Supervision Exercised : None

Required Qualifications*

  • 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 2 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*

  • 4+ years of related experience 

Work Schedule

This is a full time in person 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.

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.