Regulatory Operations Assistant
Integrated Resources, Inc ( IRI )California, United States
Posted June 6, 2017
Full Time
About the Company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Job Description
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. Our mission centers on delivering only the best quality talent, the first time and every time.
Requirements
- 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
- Results Posting for Clinical Trials on CTgov 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 Client internal document standards.
- Attends and participates in routine group meetings.
- May attend cross-functional meetings under the direction of a more senior staff meeting.