Summary

The Senior Regulatory Affairs Associate is responsible for managing and coordinating regulatory and administrative requirements for clinical research within the Center for Research Advancement (CRA). This role provides expert guidance on regulatory compliance, oversees documentation processes, and ensures adherence to federal, state, and international regulations governing clinical research. The position serves as a key resource for investigators and research teams, facilitating timely submissions and approvals to support high-quality, compliant research.

This role is eligible for a hybrid work schedule. Work schedule is flexible with working hours between Monday - Friday 8.00 am to 5:00 pm. 

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

Job Duties

Regulatory Oversight

• Manage regulatory requirements for conducting clinical research across multiple, complex trials from initiation through closeout.

Primary Regulatory Contact

• Serve as the main liaison with study sponsors, regulatory bodies, investigators, and study teams throughout all study phases.

Documentation Management

• Prepare, obtain, and maintain all required regulatory documents (e.g., FDA Form 1572, delegation of authority, training logs, certifications, IRB documentation) and ensure timely updates in both paper and electronic regulatory binders.

IRB & Agency Coordination

• Liaise with IRBs and regulatory agencies to secure approvals.
• Submit amendments.
• Obtain annual renewals.
• Notify IRB and sponsors of protocol deviations, exceptions, and unanticipated events.

Stakeholder Communication

• Lead regulatory feasibility assessments, site initiation visits, monitor visits, audits, and other regulatory-related meetings.

Regulatory Submissions

• Prepare and submit applications to FDA for investigator-initiated IND and IDE studies as needed.

Compliance Guidance

• Advise investigators on compliance with federal, state, and international regulations governing clinical research.

Training & Education

• Conduct regulatory affairs training for investigators and staff, including multi-center study coordination and SOP adherence.

Policy & SOP Development

• Develop, implement, and maintain policies, procedures, and standards.
• Contribute to ongoing SOP revisions and process improvements.

Quality Assurance

• Ensure adherence to Good Clinical Practice (GCP), Human Subjects Protection, HIPAA, and institutional requirements.

Perform additional regulatory-related responsibilities as assigned.

Perform other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Strong understanding of FDA regulations, ICH-GCP guidelines, and IRB processes.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Strong verbal, written, and interpersonal communication skills.