"Clinical Research Associate/Technician"

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 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-Assistant position on the Michigan Medicine CRC Career Ladder is required.

This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children’s Hospital. Our program is renowned for our expertise in cancers like leukemia, lymphoma, and solid tumors including neuroblastoma, sarcoma and brain tumors which affect children, adolescents, and young adults. We are members of national clinical trials organizations like COG, NANT, TACL and PNOC for pediatric and AYA cancer patients. 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. As a team member, we will invest in your education, training, career development and certification.

Characteristic Duties and Responsibilities:

Experience as part of a team with 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

• Assist study teams with all aspects of clinical trial coordination including identifying potential subjects, screening subjects, consenting (minimal risk) and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
• Coordinate and facilitate correct timing of study visits and procedures with patients and clinic staff
• Coordinate the collection and integrity of research specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)
• Monitor and report abnormal or unexpected findings
• Create source documents for accurate tracking, collection, and recording of experimental data
• Utilize critical thinking skills to recognize and solve patient/participant problems including billing issues
• Work collaboratively with nurses, research pharmacy, physicians, NPs/PAs, phlebotomists and other clinical, research and administrative staff to correct/prevent protocol errors
• Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate
• Possibly attend investigator and scientific meetings
• Serve as a resource and contact person for active protocols
• Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
• Integrate the workflow of many studies running simultaneously
• Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintain knowledge of current ICH and CFR guidelines
• Assist in the completion of regulatory duties including new study activation and processing of amendments and continuing reviews
• Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• In coordination with the CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
• Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues

Supervision Received:

This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator). Functional supervision may be received from the Clinical Research Coordinator Senior in the team.

Supervision Exercised:

None.

Required Qualifications:

• Bachelor's Degree or higher preferably in health science or health related field or an equivalent combination of related education and experience.
• At least two years of experience coordinating Clinical Trials.
• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Excellent computer skills including proficiency in Microsoft software applications.
• Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.
• Willingness to be flexible in a dynamic working environment.
• Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
• Good attendance record

Associate Level:

• 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) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
• Minimum 2 years of directly related experience in clinical research and clinical trials.

Technician Level:

• Associate degree or an equivalent combination of related education and experience.
• Minimum 1 year of directly related experience in clinical research and clinical trials.
• OR
• 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
• OR
• 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

Assistant Level:

• High school diploma or GED is necessary.
• 4+ years of direct related experience
• Masters Degree
• Reasonable understanding of clinical research
• Understanding of medical terminology related to oncology
• Some IRB/regulatory experience
• Previous experience with Epic, MiChart, eResearch, OnCore, RedCap
• Certification or planned certification through ACRP or SOCRA

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.

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