Regulatory Affairs and Education Manager, Clinical Research Operations

The Regulatory Affairs and Education Manager will report to the Director, Regulatory and Education Program in Clinical Research Operations (CRO). The Regulatory Affairs and Education Manager will work closely with clinical research investigators, their research teams and other BCH research programs to ensure the protection of human subjects and compliance with applicable clinical research regulations/laws, institutional policies and ICH Good Clinical Practice (GCP). Responsibilities include conducting routine study audits and providing regulatory support, developing resources and education to support BCH investigators and research teams.

The Regulatory Affairs and Education Manager will be responsible for:

• Perform on-site and remote routine study audits of investigator regulatory documents and subject files to assess compliance with federal regulations, state laws and Good Clinical Practices.
• Track and analyze audit results to monitor trends of non-compliance and identify areas which BCH can improve the resources and support for investigators/research teams to facilitate compliance.
• Provide on-going support for Sponsor-Investigators in the preparation, submission and maintenance of Investigational New Drug (IND) and Investigational Device Exceptions (IDE) applications.
• Serve as a regulatory resource for the CRO, IRB/EQuIP and other BCH research programs/offices to ensure consistent and compliant collaborations that support investigators/research teams.
• Serve as a regulatory resource for all BCH investigators/research teams to navigate the research process and understand the applicable regulatory requirements, including responsibilities of sponsor-investigators related to IND/IDE, ClinicalTrials.gov registration and reporting requirements.
• Assist in the development of study tools, template, guidance documents and other educational materials and activities for the BCH research community that facilitates compliant study conduct and institutional best practices.
• Assist in the development of a curriculum for investigators/research teams that promotes compliance with applicable regulations/laws and best practices for conducting a clinical trial.
• Interacts and collaborates with clinicians, investigators, staff, and other teams and departments.
• Remain current on federal, state, and local laws governing human subject research including attendance at conferences, workshops, seminars, or lectures.
• Other education, support, or oversight activities as assigned.

In order to qualify, you must have:

• Bachelor's degree and minimum of 5-7 years of experience in human subject/clinical research.
• Extensive knowledge of GCP guidelines, and federal and state regulations governing clinical research.
• Proficient in the full suite of Microsoft Office and the ability/affinity to learn new technology applications.

Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

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