This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently.  This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.

The Division of Gastroenterology is seeking an experienced, positive, highly motivated, organized, autonomous individual with excellent communication and multi-tasking skills to join our growing research team. The Clinical Research Assistant 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 gastroenterology clinical research studies.

The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.

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.

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

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs.

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

The Clinical Research Assistant position's responsibilities include, but are not limited to the following:

• Screen, recruit, provide informed consent, and enroll participants according to protocol for clinical studies.
• Schedule participant study visits in coordination with laboratory and other clinical staff.
• Directly interact with subjects in a clinic setting including subject interviews, administering survey instruments, etc. 
• Track and monitor participants? condition and test results during the course of clinical studies. Relay relevant results to the clinical team.
• Collect and record participants study-related data.
• Collect, process, label, store, and ship bio-specimens for clinical studies.
• Complete and document participant compensation according to requirements.
• Ensure all study related documentation is completed accurately with quality and in a timely fashion per sponsor requirements. May require data entry into both electronic and paper case report forms.
• Perform clinical study supply organization and clinic room preparation.
• Manage regulatory requirements including IRB submissions in eResearch Regulatory Management system, collection of essential regulatory documents, execution of study protocol, and preparation for sponsor monitoring visits.
• Perform medical chart reviews.
• Review billing calendars and study budgets to ensure appropriate care designations and costs for clinical studies.
• Work with administrative staff to ensure appropriate billing for study-related care.
• Design source documents, recruitment materials, and other relevant study documents for clinical studies.
• Attend investigator meetings as a study team member and participate in recruitment strategies to enhance subject awareness of studies and boost subject participation.
• Attend training at sponsor site(s) or during investigator meetings.
• Work collaboratively with research team members, including training, mentoring, cross-covering for other studies when needed, and attending staff meetings.
• Assist research team in generation of presentations, abstracts, posters and manuscripts.
• Perform general office and administrative duties related to clinical studies.
• Other duties deemed necessary to maintain the smooth operation of Gastroenterology clinical studies.

SUPERVISION RECEIVED:
This position receives direct supervision and should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator.

SUPERVISION EXERCISED: none

• High school diploma or GED is necessary.
• 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.
• Ability to adhere to established timelines to accomplish tasks.
• 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.

• Associate or Bachelor 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.
• Research experience including direct interaction with research patients in a patient care setting or outpatient clinic
• Some familiarity with REDCap, OnCore, Epic, MiCHART, and eResearch applications
• IRB/regulatory experience

Work schedule may include weekend or evening hours to facilitate study recruitment but will be limited to 40 hours per week. Work is onsite.

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.

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.

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 employment opportunity employer.