Regulatory Operations Assistant

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

Gold Seal JCAHO Certified ™ for Health Care Staffing

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