Katalyst CRO · 1 month ago
Regulatory Affairs Coordinator
Indianapolis, IN
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is involved in clinical research, and they are seeking a Regulatory Affairs Coordinator to manage regulatory documentation and compliance for clinical trials. The role includes ensuring adherence to regulations, supporting clinical research teams, and maintaining regulatory files throughout the study duration.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
Bachelor's degree required
Minimum of 2 years of experience in regulatory coordination within clinical research
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
Preferred
Experience in oncology
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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