Emergency Medicine is looking for an experienced Clinical Research Coordinator to assist with multiple study projects within the Emergency Department. The candidate will assist with multiple study projects, in all aspects of clinical research including study planning and start-up, IRB management, identifying study patients, consenting and enrolling participants, lab procedures, as well as data collection. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required.

Characteristic Duties and 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

Responsible for all aspects of research regulatory compliance, such as preparation/writing of IRB protocols for submission and maintenance (including the initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, adverse event reports, etc.), while ensuring effective routine communication with the IRB. Create and maintain study standard operating procedures/protocols and research binders. Perform literature reviews. Completion of study tracking documentation accurately and in a timely manner. Create and routinely update project tracking systems. Communicate and consult with investigators and study staff to ensure alignment with research protocols and regulatory requirements.

Responsible for all aspects of research study coordination: Identifying/pre-screening potential subject records to ensure they meet study inclusion criteria, screening potential subjects, consenting and enrollment (using a variety of methods), interviewing subjects, collecting relevant clinical and demographic data, and conducting phone call follow-up assessments. Coordination of specimen collection and storage. Monitor subjects for safety and compliance with protocols. Coordination/management of all daily study operations.

May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluate results. Formulates research methods and suggests options for improving quality, identifies potential problems, recommends, and implements solutions. Consults with study staff to refine or adapt methodologies to fit research goals and specific aims. Collaborates in development of new techniques and procedures/protocols.

Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality. Regular active participation in research meetings will be expected.

This position will assist with research studies within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will routinely require covering some evening and weekend shifts. Cross training with other staff will be required.

Additional work-related tasks, not specifically outlined above, will be required of the candidate.

Required Qualifications:

• Bachelor's degree in health science or other relevant science, or an equivalent combination of related education and experience is necessary.
• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Must be organized, efficient, self-motivated, and proficient in computer skills including Microsoft software applications.
• Ability to organize and manage multiple tasks/projects simultaneously, as well as prioritize and exercise good judgment.
• Ability to work independently with minimal supervision while maintaining effective collaborations and communication with a diverse team of individuals in a diplomatic, professional, collaborative, and effective manner.
•  Candidate will be expected to prioritize multiple tasks, meet deadlines, and adhere to strict confidentiality policies.
• Must be comfortable working in the Emergency Department (following established protocols to facilitate social distancing and reduce COVID-19 transmission risks), interacting with diverse populations, and potentially discussing sensitive topics with study participants and families.

Associate:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• 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)
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

Technician:

• Associate degree in Health Science or an equivalent combination of related education and experience.
• ONE of the following:
• Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
• 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.
• 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.

• Previous clinical research experience, clinic/hospital/lab work or volunteer experience, and knowledge of the research protocols and processes are highly desired.
• The ideal candidate for this position will be able to work as a member of a collaborative team but have the ability to function independently with limited supervision after a period of on-boarding.
• Familiarity and experience with Epic, MiChart and eResearch applications. PEERS, regulatory compliance, IRB review and approval process.
• Experience with REDCap (Research Electronic Data Capture), Qualtrics or a similar data capturing system.

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

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.

This position will assist with research studies within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will be onsite for 8-hour shifts for 40 hours a week, and routine evening and weekend shifts will be required

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

Supervision Received:

This position reports directly to the Program Manager for the Traumatic Brain Injury Program.

Supervision Exercised:

None

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.

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 any time after the minimum posting period has ended.

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.