Regulatory Operations Associate

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Operations, RA Intelligence
  3. United States
Foster City, USA
Posting date: 20 Oct 2020

Proclinical is currently recruiting for a REMOTE Regulatory Operations Associate with a pharmaceutical company.

Job Responsibilities:

  • 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.

Skills and Requirements:

  • 3+ 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)

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.