Regulatory Affairs Coordinator

Katalyst CRO; Boston (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO in Boston seeks a Regulatory Coordinator to oversee regulatory documentation for clinical trials, ensuring FDA, ICH, and GCP compliance at the site.

You will support study start-up, maintain regulatory files, and act as a central resource for staff, preparing IRB submissions, amendments, and audit responses.

Qualifications

• Bachelor's degree required.
• Minimum 2 years in regulatory coordination in clinical research.
• Knowledge of FDA regulations, ICH guidelines, and GCP.
• Experience with IRB submissions and regulatory document management.
• Experience with multiple central IRBs and their submission processes.
• Proficiency with electronic systems and MS Office.
• Strong organizational skills and ability to manage multiple tasks.

Responsibilities

• Coordinate, prepare, and maintain regulatory documentation for clinical trials.
• Ensure compliance with FDA, ICH, and GCP guidelines.
• Support study start-up and maintain regulatory compliance.
• Maintain up-to-date regulatory files and binders.
• Serve as central regulatory resource for staff.
• Prepare regulatory documents for IRB submissions and amendments.
• Review consent language and align CTA language.
• Track protocol approvals, renewals, and amendments.
• Prepare responses to audit findings and implement corrective actions.
• Report adverse events (AEs) and SAE updates to the Director.

Skills

Regulatory coordination

Oncology experience

IRB submissions

FDA regulations

GCP standards

MS Office

Organization

Education

Bachelor's degree

Tools

IRB submission systems

Microsoft Office

Job description

• The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.
• This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site.
• They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects
• S/he will be responsible maintaining accurate and up-to-date regulatory files.
• S/he will serve as a central regulatory resource for staff conducting clinical research.
• This position reports to the Director of Research Services.
• Prepare, review, and submit regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations.
• Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.
• Maintain accurate and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
• Develop and maintain electronic regulatory files in compliance with institutional and sponsor requirements.
• Track protocol approvals, renewals, and amendments to ensure study compliance.
• Monitor study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
• Maintain site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation
• Assist in preparing responses to audit findings and implementing corrective actions.
• Ensure prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
• Provides study updates, deviations, and SAE reports to Director of Research Services.

Responsibilities

• The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.
• This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site.
• They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects
• S/he will be responsible maintaining accurate and up-to-date regulatory files.
• S/he will serve as a central regulatory resource for staff conducting clinical research.
• This position reports to the Director of Research Services.
• Prepare, review, and submit regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations.
• Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.
• Maintain accurate and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
• Develop and maintain electronic regulatory files in compliance with institutional and sponsor requirements.
• Track protocol approvals, renewals, and amendments to ensure study compliance.
• Monitor study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
• Maintain site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation
• Assist in preparing responses to audit findings and implementing corrective actions.
• Ensure prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
• Provides study updates, deviations, and SAE reports to Director of Research Services.

Requirements:

• Bachelor's degree required
• Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology.
• Knowledge of FDA regulations, ICH guidelines, and GCP standards.
• Experience with IRB submissions, protocol amendments, and regulatory document management.
• Experience working with multiple central IRBs, understanding their submission process and requirements.
• Proficiency with electronic systems and Microsoft Office Suite.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks efficiently.