Manager, Research Regulatory Programs, Comprehensive Cancer Center

at  Wake Forest Baptist Health

JOB SUMMARY

The Manager, Research Regulatory Program provides oversight, administration and coordination of policies and procedures related to department research programs to ensure compliance with governmental regulations and institutional policies. Assists department leadership in initiatives and implementation of research regulatory programs and policies.

EDUCATION/EXPERIENCE

Bachelor’s degree and three years’ related experience. Master’s degree preferred.

SKILLS & QUALIFICATIONS

• Excellent oral and written communication skills
• Ability to direct the work of others
• Expert knowledge of regulatory information regarding the use of humans and animals in research Demonstrated understanding of the principles of human and animal research protection standards.
• In-depth understanding of operational requirements pertaining to management and implementation of protocol process
• Skill in database and software program management
• Ability to work collaboratively and effectively with faculty, staff and external customers

• Assists department leadership with the development of policies and procedures for a research regulatory program(s). Develops targeted objectives to facilitate ethical human and animal research.
• Provide guidance for administrative, management, technical and operational functions of the research program staff.
• Provide support to faculty, staff and committee members.
• Assists department and or institutional leadership with the preparation of regulatory and audit responses and correction action commitments.
• Interprets and applies federal, state and local regulations and rules and institutional policies and procedures related to the research program(s).
• Ensures departmental compliance with the ethical and regulatory requirements for human and animal research established at the institutional level. Conducts internal department reviews and audits to ensure procedures are followed. Conducts internal investigations of compliance issues under the guidance of institutional research leadership. Assesses regulatory compliance or operational risks and develops risk management strategies in accordance with institutional research policies/procedures.
• Administer practices for measuring compliance and quality through key performance indicators and provide periodic metric reporting to leadership.
• Analyzes and evaluates ongoing program(s) to identify areas for improvement.
• Represents the program at a local and/or national level while communicating professionally and effectively with internal and external stakeholders and members of the public.
• Develops and performs training and outreach in support of the regulatory education and compliance adherence.
• Performs other duties as assigned by leadership.