The Division of Cardiovascular Medicine is currently recruiting a Clinical Research Coordinator in the Pulmonary Hypertension Program. This is a full time position.
Liaise with the present Study Coordinator to coordinate and execute sponsor and/or investigator-initiated clinical trials, including identifying, screening and consenting of patients, scheduling and conducting patient clinic visits, collecting patient and laboratory data, and diagnostic and therapeutic interventions for clinical research subjects. Act as liaison between patients, investigators, nurses, other departments, sponsors, vendors and regulatory agencies. Manage all patient research data; adverse event identification and reporting; prepare appropriate reports for investigators and/or sponsors including maintaining and completing case report forms/data management; project reports as required by sponsor, coordination and participation in site visits with the sponsor/CRO. Manage and coordinate: data related to patient participation in studies, work flow as needed by multiple studies. Maintain regulatory files; prepare IRB submissions. Coordinate recruitment of patients for pulmonary hypertension trials and patient education relative to study participation. Assist with initiation of original investigations and/or development of research projects specific to pulmonary hypertension. Collect data, supervise studies, and compile results where applicable.
Bachelor's degree in health science or health related field, or equivalent education and experience. Prefer at least two years of direct clinical research experience. This position requires excellent written and oral communication skills. The candidate should have a working knowledge of Good Clinical Practice (GCP), FDA regulations and Code of Federal Regulations (CFR); in addition, experience with the IRB application process and understanding of some medical terminology. The candidate must also possess strong leadership and interpersonal skills with attention to detail. Exceptional organizational skills are required. Candidates must be able to meet multiple concurrent deadlines. He/she must demonstrate project management ability, work well in a team setting as well as independently with the ability to exercise good judgment in setting priorities, resolving problems, applying policies and procedures, while maintaining confidentiality at all times. The ideal candidate will be proficient in health/clinical research related terminology, management of regulatory documents including institutional review board (IRB) submissions, adverse event reporting, quality assurance, data query resolution, understanding of compliance issues with regard to human subject research. Candidate should possess proficiency in computer skills, including Microsoft software applications as well as electronic databases.
Certifications through ACRP or SoCRA are preferred but not required. Familiarity with Epic, MiChart, eResearch and OnCore preferred. PEERRS or CITI training certified.
The position may require occasional travel for protocol related meetings. Some of this travel can be completed in one day, although an overnight stay will usually be required.
Hours: 40 hours Shift: Monday-Friday days Location: Cardiovascular Center
We, the staff and faculty of the U-M Cardiovascular Center (CVC) team, are committed to advancing medicine and serving humanity through living and teaching our core values of Respect and Compassion; Collaboration; Innovation; and Commitment to Excellence.
Each CVC employee is expected to understand and demonstrate that in every interaction we represent our entire organization in the care we provide and in the courtesies we extend to patients, families, and each respective team member. The CVC is dedicated to partnering with patients and families to deliver the safest and highest quality of health care. Applicants are expected to review the following PowerPoint presentation which provides an overview of the Cardiovascular Center's philosophy and culture:
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. The review and selection process may begin as early as the eighth day after posting. This opening 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: 196598
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.