Clinical Research Regulatory Project Manager

Job summary
Manages the daily operation and supervision of the Clinical Research Regulatory Affairs areaCoordinates activities with physician-investigators to ensure compliance with ethical standards in clinical researchProvides guidance and interpretation of local policies and regulations
Job seniority: mid-to-senior level
Responsibilities
• Manages all functions of the Clinical Research Regulatory Affairs team• Supports clinical research teams in assigned areas• Coordinates scheduling and logistics for meetings, sponsor/monitor visits, and training sessions• Prepares IRB submissions and study-related documents• Provides regulatory and technical guidance to clinical program managers and researchers• Assigns projects and manages work flow• Communicates job expectations and conducts performance evaluations• Maintains filing systems and prepares reports• Serves as a liaison with other institutional offices and external agencies• Stays updated on federal regulations and guidelines• Identifies areas of risk and potential non-compliance• Reviews operating procedures for efficiency and effectiveness• Handles complex problems and issues related to Regulatory Affairs• Performs related duties as required
Requirements
• Successful completion of PhD program from an accredited U.S. university• Minimum of 5 years experience in related field (7 years preferred)• Bachelor's degree or equivalent combinations of education and experience• Master's degree preferred• Preferred: Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP) or Certified IRB Manager (CIM)• Proficient to advanced computer skills• Strong organizational skills• Excellent verbal and written communication and interpersonal skills• Experience in biosafety, animal care and use, institutional ethics review, research administration, or related areas