How to Apply
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 detail work experience and training as well as the unique skills the candidate would bring to the team.
This Clinical Trials Office (CTO) position provides human subjects research regulatory support to faculty members and research team members in the conduct of UM Comprehensive Cancer Center clinical trials research projects within various oncology programs. Critical skills include: an understanding of academic clinical research and the approval process, IRB and their role in the conduct of research, FDA Regulations, and GCPs.e Form. The candidate that fills this position will be responsible for a robust caseload of studies within a short amount of time. This is not an entry level position where the basics of the IRB application process will be learned. The job expectation is to be familiar with the Federal Regulations governing Human Subjects Research and to be able to immediately apply that knowledge and experience to clinical research scenarios encountered on a daily basis.
Primary responsibilities include completing and submitting electronic Institutional Review Board (IRB) research applications to ensure compliance with University and Federal Government Regulations. Adept skills with electronic document management and electronic document control are vital to success in this position. Responsibilities: Maintain Regulatory Research records for several assigned oncology clinical trials. Job specific tasks include maintaining binders that document the history of the study, writing & revising Informed Consent Documents that are presented to potential research subjects; processing & submitting protocol amendments when the study changes; creating SAE spreadsheets; submitting SAE reports, submitting DSMB reports and scheduled continuation renewals as well as study termination reports. Also responsible for creating clinicaltrials.gov study registrations (and subsequent updates); filing, procuring signatures from Investigators and study team members; collecting CV's from Investigators; obtaining associated paperwork and numeric values such as lab normals/CLIA; managing files (in hard copy and via spreadsheet) and maintaining copies of current paperwork such as current IRBMED rosters; updating regulatory document information (i.e. updating 1572s, financial disclosures, etc.); creating and organizing information to ensure accurate submissions to obtain IRB approval; gathering study renewal information from study team; attending program team meetings and participating as an actively engaged member of the Regulatory Team.
Qualifications Clinical Research Coordinator:
Bachelor's degree in Science or a Health Science related field with 1-3 years’ data management, 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.
Qualifications for Clinical Subjects Coordinator:
Bachelor's degree in Science or a Health Science related field. 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 preferred.
A Master's degree is desired with relevant work experience in the area of Clinical Trials or scientific research support/management. Familiarity with therapeutic cancer clinical trials is highly desirable. Working knowledge of the U of M IRBMED submission systems (eResearch) is highly desirable. Working knowledge of medical terminology is highly desirable.
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
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.
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.
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.