Intermediate Associate Regulatory Analyst

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How to Apply

Remote applicants will be considered.

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.

Job Summary

The primary mission of the University of Michigan Medical School Office of Research is to foster an environment of innovation and efficiency that serves the Medical School research community and supports biomedical science from insight to impact. To that end, our team is constantly striving to enhance the research enterprise, including maintaining an investigator-focused infrastructure, facilitating and diversifying investigators' avenues for funding, and streamlining research processes.

The UMMS Office of Research has numerous reporting units and programs such as the Michigan Institute for Clinical & Health Research (MICHR), the Clinical Research Calendar Review & Analysis Office (CRAO), the Fast Forward Medical Innovation, the Biomedical Research Core Facilities (BRCF), the Institutional Review Board (IRBMED), and the Medical School Grant Services & Analysis Office. Together, these teams provide the necessary support to position our researchers for success.

Mission Statement

The mission of the Institutional Review Board of the Medical School (IRBMED) is to protect the rights and welfare of participants in clinical trials and other human subjects research studies by careful review and monitoring of research in accordance with applicable laws, regulations, and University policies. The IRBMED assists investigators with the design and conduct of research projects to minimize risk to human participants, provides guidance to the University and its researchers on ethical and procedural issues related to the use of human participants in research, and facilitates compliance with governmental and University policies pertaining to human subjects research. To perform its review, approval, and monitoring functions, the IRBMED is composed of six (6) review boards, each of which complies with applicable regulations concerning membership and conduct. The IRBMED oversees the protection of human participants in research conducted at Michigan Medicine which includes the University of Michigan Medical School and the UM Health System (UMHS) as well as research conducted off-site by faculty and staff as University employees or in connection with their University appointments. The IRBMED also reviews FDA-regulated research or medical intervention research conducted by faculty and staff from other U-M units including Dentistry, and the campuses of U-M Ann Arbor, Flint and Dearborn. IRBMED serves as IRB of Record for multi-site research or for individual investigators via use of IRB Authorization Agreements, including the nationally recognized SMART IRB agreement.

The IRBMED is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

Responsibilities*

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. The individual in this role will be responsible for the following items within the IRBMED Office:

• 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, support of single IRB activities, 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 regulatory materials related to human participant protection.

Required Qualifications*

• Bachelor's Degree

• 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

Desired Qualifications*

• 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

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .

Background Screening

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.

Application Deadline

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 Detail

Job Opening ID

256608

Working Title

Intermediate Associate Regulatory Analyst

Job Title

Research Compliance Spec Inter

Work Location

Ann Arbor Campus

Ann Arbor, MI

Modes of Work

Mobile/Remote

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Medical School

Department

MM Institutional Review Board

Posting Begin/End Date

11/08/2024 - 11/22/2024

Career Interest

Research

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