Premier Research Careers

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