Integrated Resources Inc.
Healthcare & Life SciencesDirect SmartRecruiters career site

Clinical Records Associate

Location
Foster City, CA · On-site
Job type
Contract
Level
Senior
Listed
30 days ago

Skills & highlights for this role

  • GCP regulations
  • ICH guidelines
  • GLP regulations
  • Trial Master File management

About the role

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

About the role

Must meet all requirements for Clinical Records Assistant position and have demonstrated proficiency in all relevant areas. Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records. Maintain a working knowledge of clinical, biometrics, and preclinical documents.

Participate in continued security and maintenance of the Trial Master File (TMF) Room. Assist in the development and implementation of procedure s for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records. Assist in the development of Trial Master File SOPs. Assist with the training of Client and contract employees on the TMF SOPs.

Participate in the management of vendor relationships including offsite storage. Create and maintain study specific file structures for Client clinical, biometrics, and preclinical documents and file documents accordingly. Ensure record filing is kept up to date and is performed accurately.

Perform an inventory review for incoming CRO clinical study files; receive, index, and file preclinical study records; responsible for offsite archival of documents; participate in periodic file room utilization reviews; file incoming documents and retrieve documentation from the TMFR upon request. Ensure appropriate documentation completed to track archival of files.

May provide support during TMF-related regulatory agency and internal GCP inspections. Assist in the development of electronic tracking/ filing systems.

Additional Information

Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing "INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

About the Company

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Read the original posting

From Integrated Resources Inc.'s careers page, first listed on Rolev.ai on October 10, 2026. Rolev.ai is not the employer.

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Common questions

Where is the Clinical Records Associate job at Integrated Resources Inc. located?

This Clinical Records Associate position at Integrated Resources Inc. is located in Foster City, CA (On-site). Always check Integrated Resources Inc.'s application page for specific state eligibility or relocation policies.

What qualifications are required for Clinical Records Associate at Integrated Resources Inc.?

For the Clinical Records Associate role, Integrated Resources Inc. highlights experience with GCP regulations, ICH guidelines, GLP regulations, Trial Master File management. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.

How do I apply for the Clinical Records Associate position at Integrated Resources Inc.?

This listing links directly to Integrated Resources Inc.'s SmartRecruiters application page. You can apply directly on Integrated Resources Inc.'s site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the SmartRecruiters application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.