Title:  Senior Research Compliance Associate

Summary

The Senior Research Compliance Associate will serve as the primary point of contact for negotiating and determining which multisite research qualify for reliance by either: 1) BCM IRB relies on the review of an external IRB, or 2) BCM IRB serves as the single IRB for other sites involved in the research.

This role is eligible for a hybrid work schedule.

Job Duties

• Review, negotiate terms and conditions, and facilitate the review of and execution of reliance agreements.
• Oversee, coordinate, and document the activities related to institutional responsibilities as outlined in the reliance agreements and/or dictated by federal, state or local laws and policies.
• Serve as the regulatory contact and work with BCM investigators who wish to establish reliance on BCM as the IRB of Record or rely on an external IRB for multisite research.
• Assist the HRP Director to develop policies, procedures, and tools to facilitate and streamline practices related to the reliance agreement review process, institutional responsibilities, and local review as applicable.
• Oversee the reviews of local considerations for studies as outlined in the terms of the reliance agreements (i.e., verifying training of the research team, reviewing consent forms for local context, work with RCOI to review conflicts of interest, or ensuring local ancillary reviews are completed).
• Develop and implement related training/educational materials for the research community and IRB staff in coordination with the HRP Director.
• Manage and update all reports, tracking systems, and documents pertaining to reliance agreements, single IRB, and/or multisite negotiations.
• Facilitate the development and improvements in the reliance workflow with the HRP/IRB Director, and Director of Research IT, and Director of Research Compliance.
• Maintain advanced knowledge of federal regulatory requirements and institutional policies and procedures.
• Communicate College policy to departmental personnel, responds to research compliance questions and concerns.
• Develop internal procedures to ensure compliance with policy.
• Plan and organizes a variety of projects directly related to the departmental goals.
• Work with team members to ensure completion of mutual performance goals.
• Supervise the HRP administrative review of protocols relying on an external IRB; coordinate with BCM IRB associates for BCM IRB review when serving as the IRB of Record.
• Work with Senior Research Compliance Associate to develop and implement related training/educational materials for the research community and IRB staff.
• Work with RCS and the BCM IRB/HRP Director on reviews of unanticipated problems or suspected noncompliance, and reports to applicable institutions and regulatory agencies as dictated in the reliance agreements.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• IRB specific research compliance experience