Director, Research Compliance

Summary

Baylor College of Medicine's administration for research oversight seeks an individual to serve as the Director, Research Compliance. The Director will ensure the College follows federal research regulations and guidance related to identifying and managing financial conflicts of interest (FCOI) and Institutional Conflicts of Interest (ICOI). Will also work to ensure the college complies with the grants policy and does not pose any conflicts of commitment in funded research. This position will work closely with the BCM Compliance and Audit Services concerning the College's Disclosure of Outside Interests module. The Director will supervise the development of changes to forms and processes to update further and improve the electronic systems for investigator disclosures of outside interests.

This is an onsite role with future potential for hybrid work schedule.

This position is eligible for an annual performance-based bonus.

Job Duties

• Directs the staff and operations of the department's activities for Research Conflicts of Interest and Commitment.
• Provides aggregate quarterly and annual compliance reports, data, and report support for college leadership.
• Conducts complex protocol and proposal reviews, and significant financial interest reviews; serves Principal Investigators and Staff with navigating the Disclosure of Outside Interest Tool for disclosures of Significant Financial Interests (SFIs).
• Collaborates with Principal Investigators from across the college to manage FCOIs and ICOIs and ensure that all management plans are adhered to properly to comply with regulatory and college requirements.
• Serves as a subject matter expert on regulatory guidance regarding requirements for managing research conflicts of interest (RCOI); applies applicable institutional policies and federal, state, and local regulations when reviewing research conflicts of interest, institutional conflicts of interest, and conflicts of commitment.
• Directs workshops and seminars regarding issues in RCOI, grants policy compliance, and conflicts of commitment to comply with regulations and college policy.
• Partners with Principal Investigators from across the college to evaluate possible research activities to ensure compliance with regulatory and college requirements related to conflicts of commitment and non-BCM research activities.
• Advises on developing, communicating, and implementing policies, procedures, disclosure form updates, disclosure system updates, and guidance for the College's research community and research oversight committees.
• Collaborates with the Executive Director of Research IT and Executive Director of Research Compliance to develop and implement improvements for more efficient workflow.
• Oversees the review of the proposal/protocol process review to ensure regulatory compliance; advises research leadership of needed changes to organizational and operational processes and standards.
• Advises the College's research leadership of needed changes to organizational and operational processes and standards based on federal research regulations.
• Develops and assesses, on an annual basis, internal procedures to ensure compliance with the policy.
• Prepares complex and frequent external communications to federal oversight agencies and regulatory bodies.
• Plans, organizes, and implements various projects directly related to the mission's strategic goals.
• Provides additional new and ongoing training to current and new staff.
• Works with team members to ensure the completion of mutual performance goals.
• Builds and maintains effective relationships with Investigators.

Minimum Qualifications

• Bachelor's degree.
• Eleven years of directly related experience with four years of supervisory experience.

Preferred Qualifications

• Master's degree. Seven years of directly related experience with four years of supervisory experience.
• Knowledge of research administration and/or research experience.

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

15676

SN