Clinical Research Coord Assoc/Tech/Assist

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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.

　　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:

　　Scientific Concepts and Research Design

　　Ethical Participant Safety Considerations

　　Investigational Products Development and Regulation

　　Clinical Study Operations (GCPs)

　　Study and Site Management

　　Data Management and Informatics

　　Leadership and Professionalism

　　Communication and Teamwork

　　Clinical Coordinator Responsibilities

　　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

　　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

　　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

　　May assist with creating posters, abstracts, and articles

　　Participates in regular study meetings. Properly completes payment forms and pays participants accordingly

　　All training requirements of previous level.

　　PEERRS, HIPAA, CITI GCP

　　eRPM` Regulatory training

　　Attends and participates in all training assigned to this level.

　　Supervision Received: This position reports directly to a CRC-Lead OR CRC-Project Manager, and Faculty Principal Investigators.

　　Supervision Exercised: None

　　Required Qualifications*

　　Associate Level:

　　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 fromSoCRA (https://www.socra.org/certification/certification-program/program-overview/) orACRP (https://acrpnet.org/certification/crc-certification/) 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.)

　　Technician Level:

　　Associate degree in Health Science or an equivalent combination of related education and experience is necessary.

　　Minimum 1 year 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.) 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.

　　Assistant Level:

　　High school diploma or GED is necessary.Desired Qualifications*

　　Associate Level:

　　4+ years of direct related experienceTechnician Level:

　　Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable.

　　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.

　　Assistant Level:

　　Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.

　　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.

　　Work Schedule

　　On site work location, 4-5 days a week depending on job needs/requirements

　　Underfill Statement

　　This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates qualifications.

　　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.

　　Job Detail

　　Job Opening ID

　　244216

　　Working Title

　　Clinical Research Coord Assoc/Tech/Assist

　　Job Title

　　Clinical Research Coord Assoc

　　Work Location

　　Ann Arbor Campus

　　Ann Arbor, MI

　　Full/Part Time

　　Full-Time

　　Regular/Temporary

　　Regular

　　FLSA Status

　　Nonexempt

　　Organizational Group

　　Medical School

　　Department

　　MM Int Med-Rheumatology

　　Posting Begin/End Date

　　1/19/2024 - 2/02/2024

　　Career Interest

　　Research

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