Job Information
University of Michigan Clinical Research Coord Inter in Ann Arbor, Michigan
Clinical Research Coord Inter
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Job Summary
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates 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. This position contributes 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. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.
This position will provide study coordination and support clinical research activities focused on the causes and risk factors of amyotrophic lateral sclerosis (ALS) in the Pranger ALS Clinic and University of Michigan ALS Center of Excellence. The CRC will work with principal investigators, clinic staff, and other research team members to accurately and efficiently coordinate and carry out a range of tasks associated with a variety of ALS specific research studies, with primary emphasis on activities associated with the newly established National Institutes of Health-funded Access for All in ALS (ALL ALS) consortium. ALL ALS is a multi-institutional effort that aims to provide large-scale, centralized, and readily accessible infrastructure for the collection and storage of a wide range of data from people living with ALS, participants at risk of developing ALS, and people with no risks or symptoms of ALS. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities and will include planning and overseeing ALS research study activities, coordinating study visits and data collection/management, and preparing required reporting for governmental agencies. 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.
Responsibilities*
Expert level 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
Specific Responsibilities:
Oversee the planning, organization, and assignment of study activities for ALL ALS and other research studies, focused on screening, recruiting, obtaining informed consent, and enrolling participants according to protocol.
Coordinate study-related visit activities, including scheduling, study visit coordination, subject interviews, cognitive screenings, administering survey instruments, and collecting outcome measures (e.g., vital capacity, muscle strength testing via hand-held dynamometry). Collect and ensure proper recording of participant study-related data. Manage collection, processing, labeling, storage, and shipment of biospecimens for research studies. Training in venipuncture is preferred.
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. Complete Institutional Review Board applications, amendments, etc. and ensure compliance with approved protocol activities and reporting requirements.
Meet regularly and work closely with the unit team on defining and implementing best practices, ensuring timeliness of deliverables, confirming collection of all designated study data, and verifying accuracy of data.
Serve as point-of-contact for ALL ALS Coordinating Center personnel and site coordinators to maintain study continuity, compliance, and reporting. Attend ALL ALS study meetings and conferences as appropriate.
Work collaboratively with team members and cross-cover for other studies as needed.
Supervision Received:
This position reports directly to Faculty Principal Investigator.
Supervision Exercised:
Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.
Required Qualifications*
For a Clinical Research Coordinator Intermediate level position:
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 (https://acrpnet.org/certification/crc-certification/) ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA (https://www.socra.org/) ) 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/) orACRP (https://acrpnet.org/certification/crc-certification/) prior to applying.)
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA'sDefinition of a Clinical Research Professional (https://www.socra.org/certification/certification-program/definition-of-a-clinical-research-professional/) for qualifying experience prior to applying.)
For a Clinical Research Coordinator Associate level position:
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 (https://acrpnet.org/certification/crc-certification/) ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA (https://www.socra.org/) ) 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/) 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.
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.
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*
6+ years of direct related experience
A licensed healthcare provider, such as a registered nurse, with an active, unrestricted license or ability to be licensed in the State of Michigan, is desired, along with training in venipuncture, to support study activities.
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 the CRC-Associate or CRC-Technician titles based on selected candidates' qualifications.
Additional Information
Michigan Medicine (or unit specific name) 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
251341
Working Title
Clinical Research Coord Inter
Job Title
Clinical Research Coord Inter
Work Location
Ann Arbor Campus
Ann Arbor, MI
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Neurology Department
Posting Begin/End Date
7/09/2024 - 7/30/2024
Career Interest
Research
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