Job Details

  • Title: Clinical Trials Disclosure Associate
  • Code: RCI-07888
  • Location: Foster City California (CA) 94404
  • Posted Date: 02/13/2020
  • Duration: 18 Months
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  Job Description

The Disclosure & Transparency (D&T) function resides organizationally within Regulatory Documentation & Submissions (RDS). The D&T function is responsible for clinical trial registrations and result postings in ClinicalTrials.gov (CTgov), EU Clinical Trial Register (EU-CTR), & European Union electronic Register of Post-Authorization Studies (EU PAS Register/ENCePP). D&T 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 on CTgov & ENCePP
    • Results posting of clinical trial results on CTgov, EudraCT, and ENCePP
    • Gains foundational understanding of industry regulations and guidance’s
    • Standards
    • Disclosures processes and tools
    • Acquires basic knowledge of client's regulatory document timelines
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 & ENCePP
  • Regular updates to protocol records on CTgov & ENCePP
  • Results posting for clinical trials on CTgov, EU-CTR, & ENCePP
  • Performs QC/editing of training manuals, business practices, checklist documents
  • Supports continual improvements by evaluating disclosure business process and providing suggestions to enhance compliance and efficiency
  • 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
  • Excellent verbal and written communication skills and interpersonal skills
  • Well developed computer skills including proficiency in Word, Adobe and Excel
Typical Education & Experience:
  • 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)
  • Disclosures experience (Clinical Trial Registration & Results Posting) highly preferred