Regulatory Operations Assistant - I in Foster City, CA at Apex Life Sciences

Date Posted: 7/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    7/12/2018
  • Job ID:
    866165

Job Description


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.


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
  • Disclosures processes and tools.
  • Acquires basic knowledge of 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.
  • 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)

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.