Clinical Subjects Coordinator
How to Apply
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 serve as the Clinical Subjects Coordinator for the Oncology CTSU – Clinic Research Group in the Cancer Center. The candidate will be responsible for study coordination for patients on clinical trials in the Cancer Center.
- Assist study teams with all aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
- Coordinates and facilitates correct timing of study visits and procedures with patients and clinic staff.
- Under direction of MD- orders study specific lab work and diagnostic procedures.
- Follows up for abnormal or unexpected findings.
- May perform ECG or other procedures as needed.
- Works with research lab services and staff to maintain lab supplies.
- Creates source documents for accurate tracking, collection, and recording of experimental data.
- Accurately collect, maintain, complete electronic and paper case report forms and manage patient and laboratory data for clinical research projects. Will work closely with study monitors and manage site visits. Will help with resolving queries.
- Utilizes critical thinking skills to recognize and solve patient/participant problems including billing issues.
- Communicates with nurses, IDS, physicians, NP’s/PA’s, phlebotomists and other clinical and research staff to correct/prevent protocol errors. Expeditiously routes AE and SAE information between staff , PI, and oversight agencies as appropriate.
- Possibly attend investigator and scientific meetings.
- Serves as a resource and contact person for active protocols.
- Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication.
- Integrates the workflow of many studies running simultaneously.
- Maintains current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations and maintains knowledge of current ICH and CFR guidelines.
Assist in training other staff.
- Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
- Seek the help of a Clinical Research Coordinator/Research Nurse to start complex studies and to resolve issues.
- Bachelor's Degree or higher preferably in health science or health related field
- Two years of experience coordinating clinical research or working in healthcare
- 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
- Clinical trials experience
- Previous experience with Epic, MiChart, Oncology research
- SOCRA or ACRP certification
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.
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 openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.