Senior Clinical Trial Associate - Contractor

Functional Services Oakland, California San Francisco, California Newark, California Fremont, California Los Altos, California


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a talented and energetic Senior Clinical Trial Associate to join our team! This is an exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization, changing the course of medicine.

Working at Premier Research means being an individual - you will be recognized for what you do and the impact you make. You will be working in a friendly environment with colleagues who are genuinely supportive, regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company.  Come be part of it!

As the Senior Clinical Trial Associate, you’ll have the opportunity to:

  • Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials
  • Lead the management of TMF to meet aggressive timelines
  • Participate with the auditing and reconciliation of all study related documents for trials
  • Coordinate logistics for clinical project meetings
  • Develop knowledge and expertise in therapeutic area
  • Ensure timely completion of study tasks and update trial trackers on an on-going basis
  • Follow established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks
  • Generate and distribute internal and external newsletters
  • Maintain version and quality control of study documentation and submit to TMF
  • Proactively identify and resolve clinical study issues
  • Track and qualify interested investigators

You'll need this to be considered:

  • 6+ years of relevant hands-on clinical operations experience in CRO or sponsor setting
  • Demonstrates excellent English verbal and written communication skills
  • Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
  • Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
  • Strong knowledge of ICH-GCP guidelines and other regulatory requirements
  • Must have strong experience with TMF, FDA/NDA submissions