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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.
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.
The project manager will act as a liaison to the sponsor, regulatory agencies, research subjects, IRB, and investigators. The project manager is responsible for the general implementation and conduct of clinical trials and investigator initiated studies. This includes: coordinating and overseeing research projects; oversee data entry, management and summary reports; write and/or edit progress reports and technical reports.
Manage, supervise, mentor, and develop research coordinator direct reports
Responsibility and oversight for the screening and recruitment of subjects
Lead recruitment teams and various study team meetings
Manage onboarding and training of staff direct reports
Lead in the training and development of all research staff members
Manage the collection of data for clinical research projects from various sources.
Responsible for overseeing and maintaining records related to the training of research coordinators for all protocols.
Oversee clinical research study conduct and address accordingly
Develop and track study timelines, budgets, and quality metrics
Develop and optimize recruitment strategies and participant engagement plan
Assess the operational feasibility of clinical studies while providing recommendations for execution and risk mitigation
Maintain regulatory and scientific compliance of clinical research studies
Establish protocols and operational procedures such as data collection, manual of operations, and study protocols
Interact with study teams to ensure complete and accurate study data, adherence to local and federal regulations, and protocol specific instruction.
Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance.
Data Use Agreements/Data Management:
data and years of data, formats, limitations of use agreements.
maintenance of data documentation and data dictionaries/code books.
executive management, compliance and others)
development of efficient means of sharing data without duplication of data.
new data (including sharing costs for multiple users)
access to the data needed.
Bachelor's degree in business or related healthcare or science field
At least 3 years' experience in clinical research
Experience in research and clinical study regulation and compliance, operations management, and scientific writing
Ability to be consistently detail-oriented
Excellent communication, both oral and written, and interpersonal skills
Ability to prioritize, organize, and efficiently work on multiple projects at the same time
Ability to work independently and meet deadlines
Excellent interpersonal, oral, and written communication skills
Demonstrated ability to work effectively with physicians, researchers, peers, administrators, and staff of all disciplines to enhance and improve the research experience
Demonstrated ability to collaborate in a manner that fosters team building and provides direction for team members
Knowledge of the University of Michigan IRB process
Master's degree preferred
Certified Research Administrator (CRA)
Knowledge of hospital and medical center policies and procedures
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
Job Opening ID 171168
Working Title Clinical Research Project Manager Healthcare
Job Title Clinical Res Project Mgr Hlth
Work Location Ann Arbor Campus
Ann Arbor, MI
Full/Part Time Full-Time
FLSA Status Exempt
Organizational Group Medical School
Department Anesthesiology Department
Posting Begin/End Date 4/16/2019 4/23/2019
Career Interest Research
University Of Michigan