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.
Provide data management and study coordination for clinical research trials (investigator initiated and commercially sponsored trials). Collect quality data in timely fashion recording data on case report forms and entering into database; Work closely with staff and biostatistical core to ensure compliance and assist in the analysis of data; Register patients to trial in Clinical Trials Database/with Sponsor after confirmation of eligibility; Abstract data on patients from various sources; Participate/Organize Site Visits (UofM) ; Attend Investigator Meetings (pharmaceutical studies); Ensure compliance with GCP, FDA regulations, ICH regulations, and IRB policies and procedures; Act as liaison with Regulatory Team, Study Team, federal/industrial sponsors; Management of the Study (maintain up to date protocol specific CRFs, etc); Obtain source documents for CRF completion; Prepare for Audits - internal (QARC) and external (FDA, Industry); Data Safety Monitoring preparations for PRC Executive Committee, Sponsors, Cooperative Groups, FDA; Prepare for and participate in Monitoring Visits; Prepare Ad Hoc Reports, Handle PPI special requests; Schedule/Prepare/Attend study closeout meetings; Data Entry; Specimen handling and shipping.
Bachelor's degree in Science or a Health Science related field with 1-3 years data management (0-1 year is required for the underfill), direct clinical research experience, or equivalent work experience. To be successful in this position the candidate should have a working knowledge of GCP and FDA regulations governing clinical research. Candidate must possess IT proficiency, database experience, familiarity with medical terminology, excellent written and oral communication skills and self-motivation. Candidate must demonstrate the ability to thrive in a dynamic, fast paced team environment but must also be able to work independently under limited supervision. The candidate must possess interpersonal skills with exceptional attention to detail and the willingness to contribute in a team setting. Exceptional organizational skills required. Previous research/data management experience required.
University of Michigan Health System 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.
The University of Michigan Health System 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: 153962
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.