Clinical Research Coord Assoc

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.

This position will primarily support research for the Partnering for the Future (PFF) Program, a clinical and research program that serves birthing people with Opioid and other Substance Use Disorders (OUD/SUD) as well as chronic pain. The ideal candidate will have a background in maternal health.

CRC STATEMENT:

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities.

This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC 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, demonstrate, develop, guide, and support.

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.

Characteristic

Duties and Responsibilities:

Independent knowledge, skills, and abilities within 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

Additional duties will include:

Study Interactions and Clinical Coordinator Responsibilities

• Assist multiple investigators and collaborators to monitor patient recruitment and develop plans to enhance recruitment
• Coordinate with the interprofessional team at the Partnering for the Future Clinic and community referral organizations
• Explaining studies thoroughly, reviewing informed consent, answering questions and following GCP/IRB and obtaining consent
• Execute study visits and study related procedures
• Triage complex study concerns appropriately
• Work effectively with individuals making a wide range of reproductive health decisions
• Collect of human biospecimens, as well as processing, preparing and shipping specimens to outside institutions according to study protocol requirements.
• Submit Human Subjects Incentive Program (HSIP) requests
• Coordinate with study teams at other institutions to stay up to date on study protocols and other relevant research tasks for multi-site studies
• Collaborates with medical staff to facilitate and optimize the care of research patients
• Track, document and report on study progress
• Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies
• Schedule subject visits and follow up interactions by facilitating communication between clinic/unit staff and investigators/study team
• Perform study-specific testing and oversee specialized research devices and equipment
• Investigate, modify, and integrate new procedures as needed
• Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.
• Working with Research Pharmacy in ordering and obtaining study medication
• Travelling to various clinical/social services sites within southeast Michigan
• Assist in conducting individual interviews and focus groups Various duties as needed
• Provide overnight and weekend on-call duties
• Various duties as needed

Data Responsibilities

• Create case report forms, questionnaires and study related documents
• Complete study documentation in various data systems
• Responsible for data entry, management, cleaning and database creation for several studies
• Triage complex data concerns appropriately
• Abstract data from the medical record
• Review collected data and perform data quality assurance of the collected data
• Create reports on the completeness and quality of the collected data
• Assist with…