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    Clinical Regulatory Coordinator

    Katalyst Healthcares & Life Sciences
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Regulatory Coordinator (CRC) / Clinical Regulatory Specialist (CRS)
    Company: Katalyst Healthcares & Life Sciences
    Location: [Location]
    Contract Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences is hiring entry-level candidates for various positions in Clinical Research, Drug Safety, and Pharmacovigilance. We offer opportunities in contract research for clinical trials involving drugs, biologics, and medical devices, working with university hospitals, pharmaceutical companies, and recruiting partners.

    Job Description:

    We are seeking a detail-oriented Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS) to join our expanding Regulatory Team. This role involves collaborating closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities. As a key liaison between Site IRBs and the clinical team, the CRC/CRS will manage regulatory queries, submissions, and compliance documents.

    Responsibilities:

    • Work with Clinical Operations and Regulatory Affairs to ensure regulatory compliance.
    • Act as a liaison between Site IRBs and the clinical team to resolve regulatory queries and concerns.
    • Assist in the submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews.
    • Oversee reporting of AEs, SAEs, IND safety data, violations, deviations, and other study documents.
    • Troubleshoot regulatory processes and procedures to address issues.
    • Review and develop training modules on regulatory compliance and GCP requirements.
    • Investigate deviations and monitor Corrective and Preventive Actions (CAPA) for non-compliance.
    • Maintain Trial Master Files (TMF) and Standard Operating Procedures (SOPs).

    Skills:

    • Working knowledge of internal SOPs, FDA/ICH guidelines, and Good Clinical Practices (GCPs).
    • Experience with Trial Master File (TMF) and eTMF (e.g., Veeva) is preferred.
    • Familiarity with Electronic Data Capture (EDC) systems, such as Inform, for clinical trials.
    • Strong organizational skills, attention to detail, and ability to prioritize tasks in a multi-task environment.
    • Ability to work independently and demonstrate good judgment and decision-making.
    • Oncology experience is a strong preference.

    Education & Experience:

    • Bachelor's degree or higher in Life Sciences, Health Sciences, Nursing, Pharmacy, or related fields.
    • 0-4 years of experience in clinical research in academic and/or industry settings, with a preference for oncology experience.

    Additional Information:

    • All information will be kept confidential according to EEO guidelines.

    Apply Now: Katalyst Healthcares Careers

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