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.
On the interview day, a sample Clinical Trial Protocol or Abstract/Manuscript written by the applicant will be requested.
The Choi Research Program within the Division of Pediatric Hematology/Oncology and Blood and Marrow Transplant (BMT) is seeking a Clinical Research Project Manager to support clinical research projects within her research program. The Project Manager will support the administrative duties of various clinical and translational research protocols, manage grants and the budget, coordinate activities of each of the research protocols, manage research assistants/staff, and lead the development of research protocols (i.e., maintaining timelines and writing progress reports and program evaluations). The Project Manager will lead team meetings independently with research assistants, problem solve work flow or process issues, and lead communication between human subject participants, research staff, regulatory staff, and research investigators. Importantly, the Project Manager will work closely with the PI (Sung Choi) to plan the research protocols and timelines and staffing.
Write Clinical Trial Protocols and Abstracts/Manuscripts (17%)
Complete Institutional Review Board (IRB) applications including edit and renew applications, create amendments as required per protocol, correspond with IRB and other core committee staff, generate IRB approved consent forms (15%)
Consent research participants for clinical research studies/trials
Prepare appropriate reports on each research patient, maintaining and completing the supplied case report forms for investigator and/or sponsor
Coordinate the handling of study medications
Create and manage required clinical research billing calendars
Screen and have oversight for the recruitment of subjects per study protocol
Supervise the scheduling and the collection, processing and analysis of data
Collect specimens, monitor subjects and ensure patient’s response to therapy is adequate to continue on study
Assist in the reporting of test results (36%)
Lead and participate in conferences related to the project and/or its progress
Collect and manage patient and laboratory data for clinical research projects
Coordinate communication between team members re: opening/closing of protocols, new information/amendments and administrative requests from study sponsors
Coordinate communication between departments: ie: to ensure pathology is aware of new diagnoses and the submittal of pathology material, radiation therapy to ensure the appropriate data is submitted and patients receive RT at the appropriate time
Submit Data Safety reports to the Data Safety Management Board and IRB
Build and maintain regulatory binders for each study
Design work flow and participate in quality assurance measures and coordinate study site visits
Facilitate audits from sponsor institutions or internally (32%)
5-years of clinical research experience
5-years of handling IRB/regulatory documentation
Excellent communication skills, both verbal and written
Excellent interpersonal and organizational skills
Ability to organize/prioritize tasks effectively and efficiently
Ability to meet milestones and deadlines
Ability to set goals, promote teamwork and problem solve
Ability to write Clinical Trial Protocols and Abstracts/Manuscripts and Progress Reports
Excellent computer/technological skills Demonstrated ability to lead a team
Demonstrated work ethic and reliability
Demonstrated ability to take an idea from concept to implementation
Demonstrated ability to manage work across a set of diverse stakeholders (human subjects, research assistants, research investigators, regulatory staff)
Demonstrated ability to write manuscripts and progress reports
Evidence of qualifications is provided by previous employment, references and performance evaluations.
Master’s Degree in Public Health or Epidemiology
Experience with mobile health app projects
Experience in healthcare and/or academia
Experience with Pediatric Oncology/BMT/Complex Patient Care
Experience with multi-institutional protocols
Experience with the University of Michigan’s eResearch system
Reasonable knowledge of University research policies, procedures and computer systems
Evidence of qualifications will be provided by previous employment, references and performance evaluations.
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.
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: 182792
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.