Summary

The Regulatory Affairs Associate will oversee regulatory requirements for Protocol Development and Investigational New Drug studies in the Department of Pediatrics, Center for Research Advancement. Primary responsibilities will include serving as regulatory contact with investigators, study team, and regulatory bodies throughout study development, maintenance and closure process. Position will interact with government agencies, such as the Food & Drug Administration and the National Institute of Health on specific regulatory requirements, applications, audits, and reports. Candidates should be comfortable working and navigating federal compliance systems and processes (FDA Applications).

This position is eligible for a hybrid work schedule.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

• Advises Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
• Maintains knowledge of federal regulations, and applies a detailed understanding of BCM internal processes and outside Institutional Review Board (IRB) guidelines.
• Submits studies for review and approval to FDA and internal and external Institutional Review Boards; submits amendments and annual reports.
• Communicates status to Investigators, study team and CRA leadership as requested.
• Participates in protocol development and clinical trial feasibility meetings, study implementation, compliance audits, and other on-site meetings as required.
• Partners with the applicable Study Teams within the Center for Research Advancement (Regulatory, Clinical, Quality Assurance, Finance).
• Conducts compliance audits and reviews, and participates in internal quality assurance reviews.
• Oversight of regulatory assignments, regulatory documents, and regulatory processes as mandated by the IRB and FDA regulations.
• Develops Informed Consent Form templates to be used by BCM site and multi-center sites if applicable.
• Implements and maintains appropriate regulatory policies, procedures, and standards.
• Contributes to the ongoing revision/improvement and implementation of Center for Research Advancement standard operations procedures.
• Notifies IRB of all protocol exceptions, deviations, new information and unanticipated events.
• Assists with submitting reportable events to the FDA.
• Works within BCM and FDA systems and databases (IRB, CTMS) to maintain study compliance.
• Assist in other aspects of Regulatory Affairs as needed.
• Assists with investigator-initiated studies that require protocols and related documents be developed internally.
• Prepares and/or obtains all regulatory documentation for studies, including but not limited to: study-specific FDA Form 1571, 1572, and 3674. investigator signature pages, delegation of authority form, training logs, laboratory certifications and credentials, IRB documentation, IBC submissions/approvals and membership list and the following documents for each investigator: Financial Disclosure Form, Institutional Conflict of Interest Form and certifications for Good Clinical Practice, Human Subjects Protection and HIPAA.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Preferred Qualifications

• Prior experience working in an academic research setting strongly preferred.
• Strong attention to detail, time management, and data quality.
• Ability to understand and manage the complexities of regulatory documentation.