Clinical Research Coordinator Associate

Details

Posted: 28-Mar-24

Location: Ann Arbor, Michigan

Salary: Open

Categories:

Staff/Administrative

Internal Number: 246868

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.

The Michigan Medicine Anesthesiology Department is seeking an experienced, positive, highly motivated, organized, and autonomous individual with excellent communication and multi-tasking skills to join our growing research team. This position will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of research studies. This position will provide study coordination for multiple clinical research studies of any complexity. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

This position provides study coordination for multiple clinical research studies of any complexity and in multiple patient care settings. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others. This position 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, develop, evaluate, lead, guide, mentor, and support.

This clinical research coordinator (CRC) position will support the multiple clinical research studies. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required.

This role will support Trajectories of Recovery after Intravenous propofol vs. inhaled VolatilE anesthesia (THRIVE), HSK3486-309, and TAK-925-1501 Trials.

THRIVE is a prospective, multi-center, observational study combining data from patients surveys, EHR, and wearable devices.

HSK3486-309 is a global, multi-center, phase 3, double blinded RCT comparing the pain of injection of a commonly used medication to an investigational product.

TAK-925-1501 is a multi-center, phase 2a, placebo controlled, double blind RCT looking at the effects of the investigational product on obstructive sleep apnea patients during emergence from general anesthesia.

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

• Recruit, screen, and obtain consent for potential research subjects for clinical trials within the department.
• Communicate with study participants via email and phone for recruitment and screening, scheduling study visits, troubleshooting study technology, and other compliance follow-up.
• Enter patient research data into electronic data capture systems, such as OnCore, MQUARK, REDCap, and MyDataHelps, as well as paper case report files. 
• Maintain patient safety perioperatively while collecting data.
• Utilize standard operation procedures and electronic data capture systems to track recruitment and retention of participants.
• Collect and record clinical measurements, including blood pressure, vital signs, and other health measurements.
• Traveling between sites to complete study tasks such as consenting and enrolling potential research participants.
• Assist in preparing for internal and external audits and reports, such as regulatory compliance and sponsor milestones.
• Hybrid position requiring the possibility of traveling to different Michigan Medicine locations to meet with research subjects

Supervision Received: This position reports directly to a CRC-Intermediate.

• 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.)
• Interest in clinical health research
• Excellent organizational skills and attention to detail
• Superb interpersonal skills: comfortable speaking with healthcare providers and patients and working independently and as a member of a research team.
• Ability to communicate effectively and professionally in both verbal and written form
• Ability to communicate research study details clearly over the phone

• 4+ years of direct related experience
• An understanding of medical terminology
• Experience in interviewing research participants
• High degree of comfort with smart phones, app installation, videoconferencing software, and other remote tools.
• Experience using MiChart, LabVantage, REDCap, and OnCore helpful

Hybrid: 1 to 2 days at home per week. Varies due to the types of studies and the amount of in-person work that needs attention.

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.

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.

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.

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.

The University of Michigan is an equal opportunity/affirmative action employer.

 

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About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.
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