Senior Clinical Trial Associate - Contractor
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