Senior Regulatory Affairs Associate - Clinical Research

Summary

Primarily manages regulatory portfolios or clinical research protocols of high complexity, under minimal supervision. Develops and implements regulatory strategies, ensures compliance, and facilitates product development and approvals. Acts as a key liaison with investigators, sponsors, government agencies, and IRBs, providing expert guidance and handling intricate regulatory submissions and reporting. This is a very fast paced role working with many moving parts which could include submissions to several different institutions.

After initial training period this role may be 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

• Serves as not only the primary individual responsible for obtaining regulatory approvals but also as the project manager responsible for overall project readiness and protocol implementation.
• Collaborate with cross-functional teams to ensure regulatory compliance and successful product development.
• Create, collate and confirmsthe content of all submissions to the FDA for investigator-initiated trials (IIT) INDs. Such submissions include initial submissions, adverse events, amendments to clinical trial/manufacturing activities, and treatment as well as manufacturing deviations.
• Create IND Annual Reports inclusive of coordinating data flow between principal investigators (PIs), study coordinators, and statisticians providing real time review/revision of data for completeness and correctness.
• Generate, coordinate, and confirm the content of all communications with the IRB of record and all IRB reliance approvals including initial submissions, renewals, adverse events, and deviations.
• Create and confirm the content of all submissions to Feasibility Review Committee.
• Work with the external stakeholders CRO and Finance team to meet their standards.
• Create and confirm the content of submissions to the Protocol Review and Monitoring Committee including initial submissions, protocol amendments, and annual reports.
• Create and confirm the content of submissions to the BCM Institutional Biosafety Committee including initial submission, protocol amendments, manufacturing changes (as appropriate), and annual reports.
• Create and confirm the content of submissions to the Data Review Committee/Data Safety Monitoring Board including annual reports, serious adverse events, and deviations that include risk to a subject(s).
• Serve as the primary point of contact with the sponsor and/or their Clinical Research Organization (CRO) for all regulatory aspects of the research study including study activation and termination.
• Serve as the primary point of contact for IIT studies including study activation and termination.
• Open, create, maintain through frequent updates, and coordinates closure/results reporting for IIT studies in the clinicaltrials.gov website.
• Develop and implement regulatory strategies for clinical studies and product approvals.
• Assist with protocol development and consent form development for investigator-initiated studies.
• Facilitate study monitoring and manage regulatory audits and inspections.
• Perform other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Experience with clinical research regulatory affairs
• Must have experience with managing multiple projects in different phases at one time, very fast paced environment