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.
The Division of Pulmonary and Critical Care Medicine is currently seeking a Clinical Research Coordinator. The selected candidate will perform clinical research within the University. This position supports observational, clinical trial, and translational ILD research projects funded by a variety of sources. Duties include, but are not limited to:
Coordinates and executes designated clinical trials, including procurement of space, supplies, and related equipment; screening and enrolling patients; carrying out subject study visits; data entry; and follow up with subject and study physician regarding any health concerns of the patient.
* Prepares IRB and feasibility analysis while negotiating new clinical trial work.
* Coordinates recruitment of patients for all ILD focused clinical trials and patient education relative to study participation.
* Prepare comprehensive reports in the form of source documents, notes to file, etc., on each research patient, along with maintaining and completing the supplied case report forms; prepare project reports as required by PI and sponsor.
* Manage all patient research data for assigned clinical trials; including data entry and preparing appropriate reports for sponsors and/or principal investigators.
* Responsible for managing the regulatory aspects of assigned trials, including amendments, continuing reviews, adverse event reporting, serious adverse event reporting.
* Coordinate with Research Pharmacy and the study sponsor with the handling of study medication to and from the subject.
* Participate in conferences and investigator meetings related to the assigned clinical trials in order to learn of new developments or the progress of the trial.
* Assist in maintaining a study database; organize data search, and analysis procedures.
* Act as a liaison between patient, investigators, project manager, other departments, sponsors, vendors, and regulatory agencies.
* Willing to perform spirometry if necessary. These skills can be taught on the job.
* Process and store biological samples (blood) from patients in a safe and consistent manner (training will be provided).
Bachelor's degree in a health science discipline required.
Ideal candidate will have knowledge of good clinical practice (GCP), responsible conduct of research, HIPAA and and experience with IRBMed submissions.
Two or more years research experience with patient centered research protocols including industry, government and investigator initiated studies.
Outstanding organization skills and attention to details and deadlines required.
Must be able to work independently and have excellent interpersonal skills to interact with investigators, attending physicians, nursing staff, patients and their family members.
Master's degree preferred.
Previous experience with the coordination and management of clinical trials is preferred.
Previous experience with eResearch Regulatory Management system preferred.
Experience with IRB policies and procedures preferred.
Background in nursing, respiratory or other health care field preferred.
SoCRA or ACRP certification (or willingness to become certified)
Able to perform phlebotomy via venipuncture or willingness to train.
Work Schedule: 40 hours, full time. Exempt. Some weekend and night coverage will be required, must be able to accommodate a flexible schedule as necessary in inpatient research.
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 173203
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.