Regulatory Operations Assistant

Regulatory Operations Assistant

Clinical Trail Disclosure & Transparency: The Disclosure & Transparency function resides organizationally within Medical Writing.

The Disclosures function is responsible for clinical trial registrations and result postings in ClinicalTrials.gov and the EU Clinical Trial Register. Disclosures is also responsible for the EMA Policy 0070 (Publication of Clinical Data and Reports) activities. Project Involvement: Does not participate formally in cross functional teams, but may attend team meetings under direction of a more senior staff member. Key Contributions: Under close supervision, conducts Disclosures activities including:

• Registration of Clinical Trials
• Results Posting for Clinical Trials and EudraCT
• 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 internal document standards.
• Has strong organization skills and attention detail, along with ability 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.

Qualifications

• 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)

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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