Regulatory Operations Assistant

Regulatory Operations Assistant

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.

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.

Qualifications

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

Careers Integrated Resources Inc