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    Clinical Records Associate

    Integrated Resources Inc
    0-2 years
    Not Disclosed
    Foster City
    10 March 21, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Clinical Records Associate II
    Company: Integrated Resources, Inc. (IRI)
    Location: Foster City, CA
    Type: Full-time, 12-Month Contract

    Company Description:

    Integrated Resources, Inc. (IRI) is a premier staffing firm recognized as one of the tri-state's most well-respected professional specialty firms. Since its inception in 1996, IRI has built its reputation on excellent service and integrity. IRI specializes in providing quality resources in four key areas:

    • Information Technology (IT)
    • Clinical Research
    • Rehabilitation Therapy
    • Nursing

    Job Description:

    Title: Clinical Records Associate II
    Location: Foster City, CA
    Duration: 12 Months

    Responsibilities:

    • Meet all requirements of the Clinical Records Assistant role with demonstrated proficiency in relevant areas.
    • Maintain an understanding of GCP, ICH, and GLP regulations related to clinical trial documentation and preclinical study record retention.
    • Maintain a working knowledge of clinical, biometrics, and preclinical documents.
    • Participate in the continued security and maintenance of the Trial Master File (TMF) Room.
    • Assist in developing and implementing procedures for establishing, securing, and maintaining Trial Master Files (TMF) for clinical and preclinical study records.
    • Support the development of TMF SOPs and assist in training internal and contract employees on TMF SOPs.
    • Manage vendor relationships, including offsite storage providers.
    • Create and maintain study-specific file structures for clinical, biometrics, and preclinical documents and ensure accurate filing.
    • Keep record filing updated and ensure accuracy in documentation.
    • Perform inventory review for incoming CRO clinical study files and oversee the receipt, indexing, and filing of preclinical study records.
    • Manage offsite archival of documents and participate in periodic file room utilization reviews.
    • Retrieve documents from the TMF Room upon request and ensure appropriate documentation for archival tracking.
    • Provide support during TMF-related regulatory agency and internal GCP inspections.
    • Assist in the development of electronic tracking/filing systems.

    Requirements:

    • Proficiency in clinical records management processes.
    • Knowledge of regulatory guidelines, including GCP, ICH, and GLP standards.
    • Experience with Trial Master File (TMF) management and SOP development.
    • Ability to train and mentor staff on TMF procedures.
    • Strong organizational skills with attention to detail.
    • Experience managing vendor relationships and offsite storage.
    • Strong analytical and problem-solving skills.

    About Integrated Resources, Inc.:

    IRI is an INC 5000’s fastest-growing, privately held company for the 8th consecutive year. The company is JCAHO Certified for Health Care Staffing and provides superior staffing solutions across multiple industries.

     

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    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |