Job Title:
Clinical Records Associate - II
Company:
Integrated Resources, Inc.
Location:
Foster City, CA (On-site)
Job Type:
Full-time
Duration: 12 Months (Contract)
About the Company:
Integrated Resources, Inc. (IRI) is a leading staffing firm established in 1996, known for placing quality professionals in four core areas:
Information Technology (IT)
Clinical Research
Rehabilitation Therapy
Nursing
The company is recognized for service excellence, integrity, and long-term success. IRI holds the Gold Seal JCAHO Certification and is an 8-time honoree on INC 5000’s list of fastest-growing privately held companies.
Job Description / Responsibilities:
Fulfill all responsibilities of a Clinical Records Assistant, with proven proficiency
Maintain knowledge of GCP, ICH, and GLP regulations for clinical/preclinical documentation
Assist with the security and maintenance of the Trial Master File (TMF) Room
Help develop and implement procedures for TMF and preclinical record management
Support SOP creation for TMF processes
Assist in training staff on TMF SOPs
Manage vendor relationships, including offsite storage services
Create and maintain study-specific file structures and ensure accurate document filing
Conduct inventory review of incoming CRO clinical files
Receive, index, file preclinical records, and handle archival documentation
Participate in internal and regulatory inspections involving TMF
Contribute to development of electronic tracking/filing systems
Key Skills & Knowledge:
Understanding of clinical trial and preclinical documentation
Familiarity with regulatory standards: GCP, ICH, GLP
Experience with Trial Master File (TMF) systems
Strong organizational, documentation, and recordkeeping abilities
Capability to support training and handle offsite storage logistics
Minimum Qualifications:
Demonstrated experience in a Clinical Records or Clinical Documentation role
Proficient in managing TMF and preclinical documentation in a regulated environment
Recruiter Contact:
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
Website: www.irionline.com
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