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Regulatory Operations Assistant

Integrated Resources Inc · Foster City, United States · Onsite
Corporation
0 Applicants · 19 Views · Posted 45 days ago
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Position Overview

Location: Foster City, United States United States flag
Position: Senior
Type: Job
Practice Area: Regulatory Compliance
Remote: No
Posted:
Deadline: Jul 10, 2026

Job Description

Job Title: Regulatory Operations Assistant 

Duration: 6 Months
Location: Foster City

Job Responsibilities and Skills:

  • Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
  • Registration of new Clinical Trials on CTgov
  • Regular updates to Protocol Records on CTgov
  • Results Posting for Clinical Trials on CTgov and EudraCT
  • Policy 0070 work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
  • Collection, e-organization/e-filing, and tracking of Policy 0070 required documents
  • Extraction and preparation of Policy 0070 required documents
  • Draft Auto-Redaction and Manual Redaction of Policy 0070 documents
  • Facilitation of Policy 0070 review process
  • Finalization and publication of Redacted documents
  • Preparation of other Policy 0070 materials (e.g. CCI Justification Tables, Anonymization Report, Cover Letter, Document Inventory, etc.)
  • Performs QC/editing reviews of documents such as CSRs, IBs, CTDs, and other Clinical or Regulatory documents in line with Client internal document standards.
  • Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.
  • Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.
  • Has excellent verbal and written communication skills and interpersonal skills.
  • Has well developed computer skills including proficiency in Word, Adobe and Excel.


Typical Education & Experience: 

Required:

  • 2+ years of relevant experience and a BS degree.
  • Clinical R&D experience (e.g. Clinical Operations)
  • Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP)

Not Required – But Advantageous:

  • Disclosures experience (Clinical Trial Registration & Results Posting)
  • Policy 0070 experience

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)


Practice Area

Regulatory Compliance

Position

Senior

Application Deadline

July 10, 2026

Employment Type

Full time

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