The Division of Pulmonary and Critical Care Medicine (PCCM) is a recognized national leader in the area of Asthma and Airway Disease Research. Excellent service is an expected and integral part of the PCCM culture. At this time we are conducting a large NIH-sponsored longitudinal study of asthma and the microbiome. In addition we have several other industry-sponsored grants and contracts for studies of asthma. Due to this recent growth in asthma research awards, we are seeking a well-qualified clinical research coordinator whose work will focus on our portfolio of asthma studies.
Lead study coordinator who will work in a collegial fashion with the principal investigator, research coordinators, administrators and collaborators on NIH-funded and industry-sponsored prospective studies of asthma. Manage and execute 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 and retention of subjects in longitudinal studies, oversees 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.
- Primarily assist with the execution of an NIH-funded longitudinal study of asthma, including recruitment and retention of subjects, scheduling of procedures, and collection of data.
- Perform study-specific tests in clinic or other designated research space, such as spirometry and sputum induction.
- Assist with research bronchoscopy preparations and sample collection.
- Design work flow and develop quality assurance processes for study start up, execution and conduct. Maintain accurate research records and transcribe collected data onto study documents, forms, and electronic research databases.
- Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements.
- Assists with writing, editing, and renewing of 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, sponsor regulations, and all other federal, local, and University guidelines.
- Other duties as assigned or required for the research project.
- Occasional overnight travel expected for study related meetings and conferences.
- Act as liaison between patient, investigators, other departments, sponsors, vendors and regulatory agencies.
- Health-related college degree or equivalent education and experience required.
- Previous experience with subject recruitment and retention, and coordination and management of NIH studies and/or clinical trials required, minimum 3 years.
- Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available. Clinical experience with respiratory patients is highly desired.
- Previous experience with REDCAP or a similar clinical research database desired.
- Certification through ACRP or SOCRA a plus.
- 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, coordinators, collaborators, Institutional Review Board, and Office of Research and Sponsored Projects in a diplomatic, collaborative and effective manner.
- Demonstrated problem solving and conflict resolution skills.
- Ability to multitask, work well under time constraints and meet deadlines.
- Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail.
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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.
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The University of Michigan is an equal opportunity/affirmative action employer.