The Division of Pulmonary and Critical Care Medicine (PCCM) is a recognized national leader in the area of Chronic Obstructive Pulmonary Disease. Excellent service is an expected and integral part of the PCCM culture. At this time we are conducting multiple NIH and industry sponsored grants and contracts. Due to our recent growth in research awards, we are seeking a well-qualified clinical research coordinator.
Manages study start up and execution of research studies including IRB applications in eResearch and writing informed consent documents. Collects and manages patient and laboratory data for clinical research projects. Screens and has oversight for the recruitment of subjects, supervises the scheduling of protocol required testing and the collection, processing and analysis of data. Collects specimens and monitors subjects. Consult with and advise project manager or principle investigator on relevant regulatory issues, using knowledge of federal, state and other laws/policies/procedures.
- Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data.
- Design work flow and develop quality assurance processes for study start up, execution and conduct.
- Act as liaison between patient, investigators, other departments, sponsors, vendors and regulatory agencies.
- Maintains accurate research records and transcribes collected data onto source documents and electronic case report forms.
- Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements.
- Assists with writing, editing, and renewing Institutional Review Board applications, amendments and billing calendars.
- Reconcile research billing, payments and invoices and finance issues in concert with department grant managers and financial team.
- Assures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines.
- Perform study-specific tests in clinic such as complete spirometry and walk test.
- Other duties as assigned or required for the research project.
- Occasional overnight travel expected for study related meetings and conferences.
- Health related college degree or equivalent education and experience required.
- Previous experience with coordination and management of clinical trials required, minimum 3 years.
- Previous experience with spirometric testing desired, however on-site training is available. Clinical experience with respiratory patients is highly desired.
- Certification through ACRP or SOCRA a plus or willingness to become certified.
- Certification of Good Clinical Practice Training required.
- Exceptional organizational and computer skills in Microsoft software applications.
- Ability to work with minimal supervision with diverse teams of physicians and coordinators in a diplomatic, collaborative and effective manner.
- Demonstrated problem solving and conflict resolution skills.
- Ability to multi-task, work well under time constraints and meet deadlines.
- Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail.
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.