Katalyst CRO
The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.
Responsibilities
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.
Facilitates the study start‑up approval process and maintains documentation of regulatory compliance throughout the trial's duration for studies involving human subjects.
Maintains accurate and up‑to‑date regulatory files and serves as a central regulatory resource for staff conducting clinical research.
Prepares, reviews, and submits regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations.
Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent.
Maintains accurate and up‑to‑date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
Develops and maintains electronic regulatory files in compliance with institutional and sponsor requirements.
Tracks protocol approvals, renewals, and amendments to ensure study compliance.
Monitors study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
Maintains site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation.
Assists in preparing responses to audit findings and implementing corrective actions.
Ensures prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
Provides study updates, deviations, and SAE reports to the 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.
Job Information
Seniority level: Associate
Employment type: Contract
Job function: Legal
Industry: Pharmaceutical Manufacturing
Location: Indianapolis, IN
Salary: $66,300.00 - $99,500.00
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Responsibilities
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.
Facilitates the study start‑up approval process and maintains documentation of regulatory compliance throughout the trial's duration for studies involving human subjects.
Maintains accurate and up‑to‑date regulatory files and serves as a central regulatory resource for staff conducting clinical research.
Prepares, reviews, and submits regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations.
Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent.
Maintains accurate and up‑to‑date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
Develops and maintains electronic regulatory files in compliance with institutional and sponsor requirements.
Tracks protocol approvals, renewals, and amendments to ensure study compliance.
Monitors study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
Maintains site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation.
Assists in preparing responses to audit findings and implementing corrective actions.
Ensures prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
Provides study updates, deviations, and SAE reports to the 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.
Job Information
Seniority level: Associate
Employment type: Contract
Job function: Legal
Industry: Pharmaceutical Manufacturing
Location: Indianapolis, IN
Salary: $66,300.00 - $99,500.00
#J-18808-Ljbffr