Regulatory Coordinator II - Clinical Trial Office

About the Role The Regulatory Coordinator II (RC II) supports the Clinical Trials Office by completing regulatory requirements for clinical research projects. Under the direction of the Director of Clinical Research Administration, the RC coordinates protocol submissions, prepares regulatory documents, maintains study records, and ensures compliance with DF/HCC policies and federal regulations and ICH/GCP guidelines. Collaborates with diverse stakeholders including DF/HCC investigators, industry sponsors, and external partners; works with OHRS, ODQ, and other Clinical Trials Offices. This hybrid role has two to three days on-site per week at the Brookline, MA location. What You'll Do

• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors.
• Maintains regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
• Prepares, maintains and organizes Regulatory files for each assigned study in compliance with sponsor requirements; Industry sponsor, DF/HCC sponsored etc.
• Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the FDA, OBA, etc.
• Tracks and manages assigned new protocol start-up packet; initiates, facilitates, and monitors start-up progress to ensure benchmarks are met.
• Communicates and collaborates with clinical trial key stakeholders through the start-up process, provides regular updates and ensures all start-up activities are completed.
• Creates and maintains tracking for all subsequent submissions to the SRC/IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exception, or other event reporting.
• Ensures regulatory reporting required are met, Sponsor, FDA, IRB etc.
• Establishes and maintains regular communication with study team, sponsor, regulatory agencies/offices to ensure all required information is relayed and responsible for systematic documentation/tracking when applicable.
• Serves as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation/tracking when applicable.
• Maintains working knowledge of current regulations, regulatory guidance and local policies.
• Assists Clinical Research Manager with regulatory-based training and implementation of new or revised regulation, guidance and/or local policy.
• Presents regulatory status for disease group portfolio at applicable research meetings. What We're Looking For
• Knowledge of applicable regulatory requirements and ICH/GCP guidelines, and DF/HCC policies.
• Experience preparing and submitting regulatory documentation (protocols, amendments, continuing reviews, informed consent, IND/IDE, FDA reports, SAE reports).
• Experience maintaining regulatory tracking databases and regulatory files.
• Strong collaboration and communication skills with study teams, sponsors, and regulatory bodies.
• Ability to manage study start-up timelines and ensure compliance with regulatory benchmarks.
• Ability to stay current with changes in regulations and policy and provide regulatory training as needed. Compensation & Benefits
• Salary: $61,110 - $67,900 per year.
• Work arrangement: Hybrid (2-3 days onsite per week at Brookline, MA).
• Benefits not specified in posting.