This position is within the BCM/Texas Children's Cancer and Hematology Centers and will provide clinical trials regulatory and oversight support, including IRB and FDA/IND submissions, in order to assure compliance with institutional, federal, and other requirements for clinical research. The individual must be a self-directed, flexible, conscientious and detail-oriented professional who can quickly adapt to a variety of situations.
Coordinates the Protocol and Regulatory Affairs Office, including providing leadership, guidance and training to junior staff and Investigators. Advises faculty in all aspects of protocol development and regulatory submission.
Establishes and maintains systems to coordinate planning, protocol development, data collection, and assembly of submissions to the IRB, FDA and other institutional and international agencies.
Manages submissions to meet timelines.
Applies a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications, thus enabling efficient and effective registration and approval.
Assists and advises Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
Provides assistance with development and implementation of Data Safety and Monitoring Plans.
Acts as a liaison with regulatory agency personnel, including interacting through oral and written communications regarding pre- submission strategies and follow-up of submissions under review.
Reports and responds to committee/agency inquiries or comments.
Assists with and prepares for FDA meetings, inspections and audits.
Ensures appropriate institutional oversight of activities conducted under investigator-sponsored INDs and IDEs.
Develops and maintains applicable policies and standard operating procedures to support and define the regulatory affairs function within the Protocol and Regulatory Affairs Office.
Stays up-to-date on changes in regulations as they may occur and implements appropriate updates to policies and procedures.
Facilitates communication with all applicable IRBs and institutional safety review committees.
Supports Investigators and study staff with reporting, study monitoring and site visits, as needed.
Develops an appropriate infrastructure to ensure accurate and timely tracking of all submissions.
Directly supervises regulatory coordinators and other Protocol and Regulatory Affairs Office staff.
Required: Bachelors degree in basic sciences, health sciences, nursing or pharmacy. Masters degree or additional course work preferred. Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred.
Required: Significant experience (5 years minimum) in regulatory affairs including direct involvement in supporting protocol and IND/IDE submissions.
Possesses advanced working knowledge of regulatory procedures and government practices pertaining to clinical research and drug development. Proven experience in the management of institutional, federal and international regulatory submissions.
Proven experience in personnel management. of regulatory procedures and government practices pertaining to clinical research and drug development.
Proven experience in the management of institutional, federal and international regulatory submissions.
Proven experience in personnel management.
Baylor College Of Medicine