Regulatory Operations Assistant
TLDR
Supports regulatory operations workflow from trial registrations to document redaction, ensuring meticulous QC under supervision.
Job Title: Regulatory Operations Assistant
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
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