KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge of research protocol design in healthcare disciplines preferred.
• Knowledge and skills in policy development, review, and implementation.
• Ability to demonstrate clear and concise communication.

MINIMUM QUALIFICATIONS

• Bachelor’s degree or equivalent advanced learning attained through professional level experience.
• Minimum of 3 years of relevant work experience.

• Conduct regulatory audits to ensure compliance with and responses to post-approval monitoring activity.
• Write audit reports, and be responsible to review plans that monitor and correct deficiencies.
• Partner with the Quality Assurance Officer to ensure corrective actions are actionable and consistent with institutional policy, regulatory requirements, and best practice.
• Develop tools and resources related to regulatory submissions to federal agencies, best practices for items such as monitoring research programs, good documentation and laboratory practices, and auditing tools. Resources will target compliance risks and mitigation strategies to reduce risks.
• Collaborate with the training and regulatory programs in RII to develop resources and participate in trainings on developing areas of concern.
• Create high level reports and collaborate with senior management on policy changes.
• Provide technical, regulatory advice and training that improves adherence to regulatory requirements.
• Assist the AVP Regulatory Affairs/Integrity by serving as an independent representative on complex regulatory and research misconduct allegations.
• Assist with writing reports of outcomes of the inquiry and investigations and reporting to federal, state and institutional offices.
• Additional duties may be assigned.