Regulatory Affairs Coordinator

Katalyst CRO; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Coordinator to oversee the coordination, preparation, and maintenance of regulatory documentation for clinical trials. The role ensures adherence to FDA, ICH, and GCP guidelines and supports study start-up and ongoing regulatory compliance at the site.

Responsibilities include maintaining regulatory files, serving as a regulatory resource, coordinating IRB submissions, and preparing responses to audit findings.

Qualifications

• Bachelor's degree required.
• 2+ years of experience in regulatory coordination within clinical research (oncology preferred).
• 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 and understanding their submission requirements.

Responsibilities

• Coordinate, prepare, and maintain regulatory documentation for clinical trials.
• Ensure compliance with FDA, ICH, and GCP guidelines across sites.
• Support study start-up and regulatory filings throughout the trial.
• Maintain accurate regulatory binders and electronic files.
• Serve as a central regulatory resource for staff conducting clinical research.
• Prepare responses to audit findings and assist with corrective actions.
• Report adverse events (AEs), serious adverse events (SAEs), and protocol deviations to leadership.

Skills

Regulatory coordination

Regulatory documentation

IRB submissions

Regulatory compliance

Project management

Education

Bachelor's degree

Tools

Microsoft Office

Job description

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.

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.