Sr Research Specialist - Regulatory/Compliance

Responsibilities

• Performs and oversees complex portfolio of regulatory activities for high-complexity and multi-site industry-sponsored trials, including ICF preparation, negotiation, and submission.
• Assists senior leadership with institutional regulatory compliance activities, oversight functions, and adherence to applicable FDA, OHRP, NIH, and HIPAA requirements across the portfolio.
• Serves as subject matter expert on institutional ICF language, OHRP, FDA, and FCOI policies and guidelines.
• Provides final sign-off on pre-award regulatory document packages, ensuring full congruency prior to IRB submission and study activation.
• Leads development of tracking systems for new study submissions, including post-award amendments and modifications.
• Leads preparation of complex site-specific regulatory submissions including INDs, IDEs, Expanded Access, and Compassionate Use studies (sINDs, HUDs, EAPs) in compliance with 21 CFR 312 and FDA guidance.
• Drives development and maintenance of regulatory SOPs, guidance documents, and process improvement initiatives within the SCTP team.
• Leads CTMS regulatory operations and drives optimization of pre-award tracking systems and activation metrics.
• Assist senior leadership with responses to sponsor audits and FDA inspections; supports audit readiness across the regulatory portfolio.
• Mentorship and professional guidance to Research Specialists, supporting their development in regulatory practice and institutional compliance.

Requirements

• Bachelor's Degree in health related field required.
• 5 years of experience in industry clinical trials or research operations.
• 4 years of experience in regulatory or clinical trial pre-award programs strongly preferred.
• Advanced knowledge of clinical research trials regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is required or 3+ years' experience in drug development, regulatory or clinical operations functions.
• Ability to work both independently part of a team and leading others.
• Clinical Research Professional Certification or related is a plus.

Qualifications

• Excellent analytical skills with attention to detail.
• Excellent written and oral communication skills.
• Excellent organizational and analytical skills with strong technical abilities.

Benefits

No travel needed.

Pay

N/A

Schedule

In-office three days per week.