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 have multiple industry-sponsored grants and contracts for studies of asthma. A new investigator has joined our faculty and is expanding the asthma clinical trials group by hiring a new clinical subjects coordinator. The person in this position will work closely with the lead clinical research coordinator with the goal of becoming independent and taking on more complex studies in the future. This position is ideal for someone interested in growing with the program.
The clinical subjects coordinator will be expected to work in a collegial fashion with the principal investigator, other research coordinators, administrators and collaborators on primarily industry-sponsored prospective studies of asthma. Collects and manages patient and laboratory data for clinical research projects and enters data into the electronic data capture system. Screens and has oversight for the recruitment and retention of subjects in longitudinal studies specifically registries, oversees the scheduling of protocol required testing and the collection, processing and analysis of data. Collects specimens and monitors subjects. Willingness to learn how to make changes to submissions in IRB applications in eResearch and submitting adverse events, amendments and minor submissions for expedited review.
- Primarily assist with the execution of industry sponsored clinical trials, including recruitment and retention of subjects, scheduling of procedures, and collection of data.
- Assist Clinical Research Coordinator with study-specific tests in clinic or other designated research space, such as spirometry and sputum induction.
- Maintain accurate research records and transcribe collected data onto study documents, forms, and electronic research databases. Work with Clinical Research Coordinator to perform data entry activities related to the ongoing trials.
- Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements in collaboration with the lead CRC and PI.
- Have a willingness to learn how to do IRB submissions initially renewals, continuing reviews and expedited reviews.
- 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.
- Exceptional organizational and computer skills in Microsoft software applications.
- Ability to work well with a team 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 multi-task, work well under time constraints and meet deadlines.
- Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail.
- Clinical research experience is desired but not required.
- 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.
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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.
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The University of Michigan is an equal opportunity/affirmative action employer.