Clinical Research Coord Lead

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.

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.

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.

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:

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

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.

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 examat 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…