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.
The position of Intermediate Associate Regulatory Analyst (MARA) collaborates with other IRBMED staff to perform highly competent regulatory reviews of expedited human subjects research applications submitted to IRBMED. The MARA will also conduct reviews of exempt and not?regulated applications submitted to IRBMED. Individuals will prepare materials for review by IRB members and support the full scope of activities associated with expedited, exempt, and not regulated reviews.
Applicants for this position are expected to have experience with the conduct of clinical research or research oversight. Candidates for the MARA role will function with greater autonomy in the regulatory review of increasingly complex IRB applications along with other assigned duties.
Conduct highly competent regulatory review of expedited research protocols involving human subjects. Conduct highly competent reviews of exempt and not?regulated protocols in order to issue regulatory determinations. Communicate with research study teams and IRBMED reviewers on regulatory considerations. Work with the study teams to address these issues in a manner satisfactory to the IRB.
Process and clear contingencies following IRB review. Communicate outcomes of IRBMED decisions to study teams.
Utilize electronic IRB application software for all review activities.
Support special initiatives, including policy/procedure analysis and development, development of internal guidance documents for review staff, corrective actions for compliance concerns, and educations activities, etc.
Collaborate with and back?up co?workers, including, for example, protocol review and follow?up, board management, education, compliance, and other IRBMED unit activities.
Conduct additional related responsibilities as assigned by supervisor, including support of full board meetings as indicated, and special projects.
Engage in professional development activities, including, for example, attendance and participation at regional and national meetings, professional IRB training and certification, and review of publications regarding human subject protection.
3-5 years of related experience
Minimum of 3 years of experience in clinical research or research oversight
Ability to understand and scrutinize scientific documents, including clinical research protocols and grant applications
Demonstrated communication, organizational, critical thinking, and interpersonal skills
Ability to work independently with minimal supervision
Knowledge of federal human subject protection regulations (45 CFR 46, and FDA 21 CFR 50, 56, 312, 812) as evidenced by experience and training
Ability to multi?task and prioritize daily work
Extremely proficient computer skills and strong writing abilities
Professional IRB certification or the intent to obtain professional certification within a reasonable period is preferred
Familiarity with electronic IRB application software (eResearch)
Familiarity with IRB procedures and processes
Up to six available positions at this level
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. 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: 169374
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.