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.

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

The role is eligible for a hybrid work arrangement after completing onboarding and training on site (typically about 6 months).  Employees working a hybrid schedule may be asked to attend in person meeting and trainings. 

Job Duties

• Apply a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications.
  Provide regulatory oversight of complex regulatory assignments.
• Assist and advise Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
• Conduct 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.
• Develop, implement, and maintain appropriate policies, procedures, and standards concerning projects.
• Serve as primary regulatory contact with study sponsors, regulatory bodies, investigators and study team throughout the study initiation, maintenance and closure process.
• Maintain 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.
• Act 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.
• Work within the sponsor required SIP and eBinder systems to maintain study compliance.
• Notify IRB and study sponsor of all protocol exceptions, deviations, new information and unanticipated events.
• Participate in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other on-site meetings as required.
• Contribute to the ongoing revision/improvement and implementation of SOPs.
• Assist with regulatory affairs training of entry-level employees as assigned and required reporting to clinical trial databases.
• Prepare and/or obtain 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.
• Assist in other aspects of clinical research as needed. 
• Perform other job related duties as assigned.

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. 
• Master's in Regulatory Affairs.