Clinical Research Coord Assoc

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Summary

This clinical research coordinator (CRC) 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 CRC-Technician position on the Michigan Medicine CRC Career Ladder 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 can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

This position will support research activities focused on the causes and risk factors of amyotrophic lateral sclerosis (ALS) in the Pranger ALS Clinic and University of Michigan NeuroNetwork for Emerging Therapies. The CRC will work with principal investigators, clinic staff, and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of ALS specific research studies. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities. 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, outline skills and experience that directly relate to this position, and provide three references with full contact information (name, phone number, e-mail address). If you are not providing a reference from your current position, please explain why. Applications without a complete cover letter will not be considered.

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

Specific Responsibilities:

  • Screen, recruit, provide informed consent, and enroll participants according to protocol for research studies.
  • Schedule and coordinate participants study visits.
  • Directly interact with subjects in a clinic setting including subject interviews, administering survey instruments, etc. 
  • Collect and record participants study-related data.
  • Collect, process, label, store, and ship bio-specimens for clinical studies. May require training in venipuncture.
  • Ensure all study related documentation is completed accurately with quality and in a timely fashion per study requirements. Complete data entry into both electronic and paper case report forms.
  • Perform medical chart reviews.
  • Complete Institutional Review Board applications, amendments, etc.
  • Work collaboratively with team members and cross-cover for other studies as needed.

Supervision Received:

This position reports directly to a Faculty Principal Investigator.

 

Supervision Exercised:

None.

Required Qualifications*

For a Clinical Research Coordinator Associate level position:

  • Bacheler'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 and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire. 
  • Minimum of 2 years of directly related experience in clinical research and clinical trials is necessary.

For a Clinical Research Technician level position:

  • Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
  • Minimum of 1 year of directly related experience in clinical research and clinical trials is necessary. -- OR -- 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. -- OR -- 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.

For a Clinical Research Assistant level position:

  • High school diploma or GED is necessary, with an Associate Degree in Health Science or an equivalent combination of related education and experience preferred.
  • Directly related experience in clinical research and clinical trials is preferred but not necessary.

All levels will require:

  • Professional demeanor and excellent interpersonal and communication skills.
  • Experience with Microsoft Office products (i.e., Microsoft Word, Excel, and Power Point)
  • Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
  • Outstanding organizational skills with meticulous attention to detail.
  • Strong ability to work independently, exercising good judgement, with minimal supervision.
  • Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
  • Strong problem-solving skills.
  • Demonstrated ability to learn and use new skills quickly and effectively.
  • Able to maintain data confidentiality and participant/subject/patient privacy.
  • Excellent attendance record and strong work ethic.

Desired Qualifications*

  • 4+ years of direct related experience
  • Nursing degree 
  • Experience with federally-sponsored, industry-sponsored and/or investigator initiated research studies, including direct interaction with patients in a patient care setting or outpatient clinic.
  • Experience using e-Research Regulatory Management system, OnCore Clinical Trial Management System, and MiChart, or comparable platforms.
  • Experience with Electronic Data Entry/Capture (EDC).
  • Experience using RedCap or similar data management systems.
  • A working knowledge of medical terminology and assessment of laboratory values.
  • Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations.
  • ICH-GCP certified through CITI, HIPAA, and PEERRS training complete and up-to-date, or the ability to complete training upon hire.

Work Schedule

This position involves a standard Monday-Friday, 8 a.m.-5 p.m. work week.

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.