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- Job Opening ID
- Working Title
- Clinical Res Project Mgr Hlth
- Job Title
- Clinical Res Project Mgr Hlth
- Work Location
- Ann Arbor Campus
Ann Arbor, MI USA
- Full/Part Time
- FLSA Status
- Organizational Group
- Medical School
- Emergency Medicine UM Adult
- Posting Begin/End Date
- 7/24/2014 – 7/31/2014
- Career Interest
Clinical Res Project Mgr Hlth
Manage and oversee activity at network performance sites located throughout the United States during study start-up (assure proper supplies and regulatory submissions), study conduct and preparation for clinical site visits. Serve as the liaison between the clinical site(s) and the NETT CCC to resolve any issues that may arise throughout the course of the study.
Review, track and maintain regulatory documents and master trial files.
Provide study-specific training to study staff at NETT performance sites.
Conduct ongoing site monitoring visits and assure that the clinical sites are enrolling subjects and collecting timely, accurate and complete data, and are doing so in compliance with the approved protocol version, GCP and ICH guidelines, and NETT SOPs. Prepare and submit timely reports of visit findings.
Collaborate with NETT study teams on the development of case report forms, data collection tools, training materials and data bases.
Participate in coordinator/investigator conference calls and meetings.
Minimum: Bachelor's degree in health science or health related field, at least one year of
clinical research ON-SITE monitoring, with at least two years of direct clinical research experience. Candidates applying for this position must be able to travel frequently, including overnight stays.
This position requires excellent written and oral communication skills. To be successful
in this position the self-motivated candidate should have a working knowledge of Good
Clinical Practice (GCP), as well as governmental and local regulations governing clinical
research. The candidate must possess strong leadership and interpersonal skills with
exceptional attention to detail. Candidates must be able to meet multiple concurrent
deadlines independently. He/she must demonstrate project management ability, a
positive approach, and be a pro-active team member and willing to assist other team
members as needed. Exceptional organizational skills are required.
The ideal candidate will be proficient in health/clinical research related terminology,
management of regulatory documents including institutional review board (IRB)
submissions, Investigational New Drug (IND) and Investigational Device Exemption
(IDE) submissions to the Food and Drug Administration (FDA), research study site
initiation and close out visits, study site monitoring including monitoring compliance with
research regulations, adverse event reporting, investigational material accountability,
quality assurance, data query resolution. A strong knowledge of 45 CFR part 46, and 21
CFR parts 50 and 56 necessary to excel in this position. Candidate must possess IT
proficiency in Microsoft Word, PowerPoint, Excel, Project, and Adobe office products.
Certifications through ACRP or SoCRA are preferred but not required.
The position will require travel several times each for off-site monitoring, off-site
staff training, and protocol related meetings. Some of this travel can be completed in one
day, although an overnight stay will usually be required.
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.