Summary

Serves as primary regulatory contact with study sponsors, regulatory bodies, investigators and study team throughout the study initiation, maintenance and closure process. Responsible for coordinating all aspects of regulatory and administrative oversight requirements for conducting clinical research trials.  

This role is eligible for 100% remote work schedule although ideal is hybrid (some onsite work each week).

Job Duties

• Applies a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications.
• Provide regulatory oversight of regulatory assignments.
• Assists and advises Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
• Conducts regulatory affairs training including but not limited to coordination of multi-center studies where BCM is the coordinating center and RRO SOPs.
• Submit studies to IBC for applicable studies as needed. -Develops, implements, and maintains appropriate policies, procedures, and standards concerning projects.
• Serves as primary regulatory contact with study sponsors, regulatory bodies, investigators and study team throughout the study initiation, maintenance and closure process.
• Maintains regulatory binders with the above documents as well as IRB approvals and study-related correspondence for each protocol from pre-activation through closeout, making sure to update each document as information changes or the document expires.
• Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
• Works within the sponsor required SIP and eBinder systems to maintain study compliance.
• Notifies IRB and study sponsor of all protocol exceptions, deviations, new information and unanticipated events.
• Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other on-site meetings as required.
• Contributes to the ongoing revision/improvement and implementation of SOPs.
• Assists with regulatory affairs training of entry-level employees as assigned and required reporting to clinical trial databases.
• Prepares and/or obtains all regulatory documentation for each clinical trial including but not limited to: study-specific FDA Form 1572, 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, Curriculum Vitae, Medical License, 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
• Strong attention to detail, time management, and data quality
• Ability to understand and manage regulatory documentation