The Research Regulatory Affairs Coordinator functions as a regulatory compliance and regulatory affairs expert to develop and implement policies, procedures and training. Ensures internal/external regulatory compliance in relation to the Food and Drug Administration. Collaborates with investigators and their research teams, and other involved institutional groups on IND development and management.
Duties and Responsibilities
Develops and implements regulatory strategies for Investigator initiated INDs to ensure compliance with all applicable regulatory requirements. Makes recommendations to Senior Management, Translational Research Program Leadership and CTREC regarding the specific activities and resources required to support this strategy.
Collaborates with EQUIP, Clinical Research Program (CRO), Translational Research Program (TRP) and the Clinical Trials Office (CTO) to develop standard operating procedures, policies and processes related to regulatory compliance in the conduct of clinical trials.
Updates knowledge on regulatory issues related to the conduct of clinical trials under FDA oversight.
Acts as an administrative agent of the primary investigator in communicating with the FDA, external sponsors/institutions in coordinating studies.
Coordinates multiple projects. Interprets guidelines and format requirements. Develops and tracks timelines for completion of multiple components.
Provides expert analysis, planning, consultation, facilitation and project management for investigator initiated INDs.
Knowledge and Skills Required
Work requires Bachelor's degree, and 3 years related experience. Advanced degree desirable.
Work requires specific expertise in the areas of cell and gene therapy.
Work requires experience and knowledge in the preparation of regulatory submission and supportive amendments.
Work requires experience in the interpretation of regulations, guidelines, policy statements, etc.
Work requires effective verbal and written communication skills; advanced interpersonal skills to provide effective consultation and collaboration.
Work requires the ability to work independently with minimal direction and within project teams, committees, in order to attain group goals.
Boston Children's Hospital offers competitive compensation and unmatched benefits, including an affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, and discounted rates on T-passes (50% off). Discover your best.
Boston Children's Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.
Internal Number: 2864409
About Boston Children's Hospital
Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age.