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.
This position will provide project management, regulatory and data management oversight and clinical monitoring support for multi-site trials coordinated by the Oncology Clinical Trials Support Unit (CTSU) from trial start-up through trial closeout. The incumbent will act as a liaison between the clinical sites, the CTSU and sponsors/agencies/cooperative groups to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines.
Develop and maintain study manual of operations, and standard data collection procedures, Monitoring Plan and other study documents. Maintain master trial files and manages the study progress in relation to the project timelines. Assure that the clinical sites are enrolling subjects, collecting data, and conducting the trial in compliance with approved protocol version, GCP and ICH guidelines and verify patient eligibility. Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies and conducting site initiation visits.
Conduct ongoing site monitoring visits. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRBs. Oversees the maintenance and organization of project documentation and records. Act as a liaison between the clinical site(s) and the data coordinating center to resolve any issues that may arise throughout the course of the study.
Other responsibilities may include but are not limited to; updating and revision of SPGs, training and orientation of study staff, organization of coordinator/investigator meetings. Participate in group and department initiatives. Perform other duties as assigned by management
Bachelor’s degree or higher in health science or health-related field
Strong background and/or experience in clinical research site management, regulatory management and data management
Excellent written and verbal communication skills
Strong organizational skills with ability to multi-task and prioritize
Must have exceptional attention to detail and understanding of compliance issues with regard to human subject research
Outstanding teamwork and customer service orientation
Ideal candidate will have strong knowledge of 45 CFR part 46 and 21 CFR parts 50
Willingness to travel up to 30% for monitoring trips.
Two to five years’ previous experience in the conduct of clinical trials is desired
SoCRA or ACRP certification, preferred
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: 178341
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.