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Clinical Regulatory Affairs Coordinator

2 months ago

Belmont, California, United States Katalyst HealthCares & Life Sciences Full time
Position Overview:

Katalyst HealthCares & Life Sciences is seeking motivated individuals for various roles in contract research related to clinical trials involving pharmaceuticals, biologics, and medical devices.

We currently have several openings in the fields of Drug Safety, Pharmacovigilance, and Clinical Research. Our collaborations span university hospitals, pharmaceutical firms, and recruitment partners.


Key Responsibilities:

We are in search of a meticulous clinical professional to enhance our expanding Regulatory team as a Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS).

  • Collaborate closely with Clinical Operations and Regulatory Affairs to ensure adherence to regulatory standards.
  • Serve as a communication bridge between Site IRBs and the Clinical team to address regulatory inquiries and issues.
  • Prepare and assist in the submission of protocol amendments, IND safety reports, modifications to consent forms, and ongoing reviews.
  • Oversee the reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), IND safety data, violations, deviations, and submission of other essential study documents to uphold regulatory compliance, while troubleshooting processes when challenges arise.
  • Review documentation and submissions from departments outside of Regulatory Affairs.
  • Develop training materials that align with organizational requirements in accordance with current international Good Clinical Practice (GCP) standards.
  • Conduct investigations into deviations and monitor Corrective Actions & Preventive Actions (CAPA) related to compliance issues and findings.
  • Create, review, and update all functional group Standard Operating Procedures (SOPs).
  • Maintain Trial Master Files meticulously.

Qualifications:

Candidates should demonstrate a solid understanding of internal SOPs, FDA/ICH guidelines, and regulatory compliance.

  • Experience with Trial Master Files and prior regulatory exposure is advantageous.
  • A foundational understanding of clinical trial conduct is preferred.
  • Strong emphasis on teamwork, attention to detail, and excellent organizational abilities are essential.
  • Ability to prioritize tasks and thrive in a multi-tasking environment.
  • Capability to work independently while maintaining confidentiality of sensitive information.
  • Demonstrated good judgment and decision-making skills.
  • Familiarity with Electronic Data Capture (EDC) systems, such as Inform, for clinical trials is preferred.
  • Detail-oriented with the ability to manage tight deadlines.
  • Experience with controlled clinical terminology is beneficial but not mandatory.
  • Knowledge of Trial Master Files and eTMF (e.g., Veeva) and proficiency in Microsoft Office are desirable.

Education:

A Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or a related field is required. Candidates should have 0-4 years of clinical research experience in academic or industry settings, with a preference for oncology experience.

All information will be kept confidential in accordance with EEO guidelines.