Clinical Research Coordinator Lead

Title: Clinical Research Coord Lead

Location: Ann Arbor United States

Work Location: Ann Arbor Campus

Modes of Work: Hybrid

Full/Part Time: Full-Time

Regular/Temporary: Regular

FLSA Status: Exempt

Organizational Group: Medical School

Job Description:

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.

Job Summary

The Chronic Pain and Fatigue Research Center (CPFRC), located within the Department of Anesthesiology, is seeking a highly motivated and detailed-oriented Clinical Research Coordinator to provide study coordination for multiple clinical research studies of any complexity. The CPFRC is a collaborative and collegial program that enjoys the opportunity to partner with many intramural and extramural researchers and includes longitudinal cohorts, clinical trials, health services, and translational research with funding from a variety of sponsors including NIH, industry, and others. The research team includes physicians, biostatisticians, project managers, study coordinators, data managers, and administrative support. Research trainees are added to the team on occasion.

Responsibilities*

The Clinical Research Coordinator Lead is responsible for coordinating their assigned studies and serving as a key team member. The coordinator will be responsible for the overall conduct of multiple clinical research studies related to medical cannabis and chronic pain from start to finish including, but not limited to: Study start up and initiation processes, preparation of initial IRB applications and study consents; perform screening for eligible subjects, consenting, coordinate participants? visits and relevant study assessments; functional supervision, training, and hiring of study staff in the CRC ladder; ensuring the highest data quality standards; acting as lead coordinator on clinical trials, including those with Food and Drug Administration Oversight; handle sample shipments, process subject payments, prepare for study close out, and create study related resources and standard operating procedures as needed. 

Characteristic Duties and Responsibilities:

Contribute to the development of process/tools and lead others in 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

Supervision Received:

This position reports directly to the team project manager and PI. 

Staff members in this classification are expected to work independently and regularly exercise judgment in setting priorities, resolving operational problems and the application of policies, procedures and methods, while maintaining the strictest of confidentiality at all times. A very strong work ethic is required with appreciation for the importance of complete and accurate research data and specimen handling.

Required Qualifications*

• CRC Governance Committee review and approval  

• 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) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP). 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 5 years of directly related experience in clinical research and clinical trials is necessary 

• Minimum of at least 5 years of clinical research study management 

• Demonstrable experience in working with multidisciplinary and multicultural teams. 

• Experience communicating with diverse patient populations
• Excellent interpersonal skills 
• Demonstrated ability to work successfully while meeting competing deadlines 
• Demonstrated ability to prioritize and exercise good judgment
• Demonstrated ability to learn and use new skills quickly and effectively
• Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
• Outstanding organizational skills with meticulous attention to detail.
• Experience with research regulatory requirements and documentation.

• Excellent organizational, leadership, and decision-making skills. 

• Excellent attendance and strong work ethic in past settings

• Willingness to travel throughout Michigan and nationally to conferences, as needed 

• Knowledge of and experience with IRB processes, including application submissions

• Knowledge of personal computers and Microsoft applications
• Experience using MS Excel, eResearch, and electronic data capture systems (e.g., Qualtrics, REDCap)
• Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations.

Desired Qualifications*

• Master's Degree in Health Science or an equivalent combination of related education and related experience is desirable. 

• 9+ years of direct related experience

• Knowledge of Michigan Medicine policies and practice
• A working knowledge of medical terminology and assessment of laboratory values.
• Demonstrated success working on multi-site research as both coordinating center and participating site
• Experience accessing/abstracting medical record data from MiChart/Epic/Electronic Health Records.
• ICH-GCP certified through CITI, HIPAA, and PEERRS training complete and up-to-date.
• Experience with data collection, analysis, and safe/secure management while ensuring data quality.

• Experience submitting research studies to the University of Michigan's Institutional Review Board (IRBMed or IRB-HSBS). 

• Strong ability to problem-solve and effectively prioritize workflows and PI needs.
• Experience with MyDataHelps (CareEvolution) 

• Experience with Food and Drug Administration drug trials

• Experience with studies that include Schedule I substances, such as cannabis or psychedelics

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

Modes of Work

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.

Work Schedule

This position will be on site to begin and will be eligible for a hybrid work schedule combining remote and in-office work. The position is a 40-hr/week role. 

Work Locations

Domino Farms Chronic Pain and Fatigue Research Center (Digital Trial Core)

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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.