Clinical Records Associate

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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Clinical Records Associate

Job Description

Company Description:

Job Description:

Responsibilities:

Requirements:

About Integrated Resources, Inc.:

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