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    Clinical Regulatory Coordinator/ Specialist

    Katalyst Healthcares & Life Sciences
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 2024
    Job Description
    Job Type: Full Time 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 currently hiring entry-level candidates for various roles in Clinical Research, Drug Safety, and Pharmacovigilance. We specialize in contract research for clinical trials of 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 growing Regulatory team. The ideal candidate will collaborate closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities. The role will also serve as a liaison between Site IRBs and the clinical team, managing regulatory queries and ensuring compliance with regulatory guidelines.

    Responsibilities:

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

    Requirements:

    • Bachelor’s degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related field.
    • 0-4 years of experience in clinical research, preferably in an academic or industry setting. Oncology experience is a strong plus.
    • Knowledge of FDA/ICH guidelines, Good Clinical Practices (GCPs), and regulatory compliance.
    • Experience with Trial Master File (TMF) and eTMF (e.g., Veeva) is desirable.
    • Familiarity with Electronic Data Capture (EDC) systems such as Inform for clinical trials.
    • Strong organizational and multitasking skills with attention to detail.
    • Ability to prioritize and work independently while meeting tight timelines.
    • Must maintain confidentiality and demonstrate strong decision-making and judgment skills.

    Additional Information:

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

    Apply Now: Katalyst Healthcares Careers

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