Clinical Trial Associate (CTA)
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Clinical Trial Associate to join our team in Korea to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
As the Clinical Trial Associate, you'll have the opportunity to showcase your expertise to perform tasks related to the start-up of a clinical trial in accordance with all regulations, standards, and study-specific requirements. You’ll be able to liaise and represent SSU with several members of the Study team as it pertains to Start-Up.
What you'll be doing:
- Support local team with RA, IRB, and safety applications, and site contract negotiation as required
- Support local team with import license applications as required
- Support with essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with local regulatory requirements and ICH/GCP guidelines.
- Translation review and verification
- Submit and ensure accuracy and completeness of trial master file documents and perform QC review of TMF.
- Liaise with internal team members to review areas that impact study start-up and share start-up information with the project team.
- Provide country-level intelligence on site start-up and ensure that regulatory intelligence is maintained on the central repository; maintain a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
You'll need this background to be considered:
- Undergraduate degree in a clinical, science, or health related field along with 2 years’ experience in clinical trials.
- Expertise in ICH/GCP and/or ISO14155 requirements as well as knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Strong verbal and written communication and negotiation skills; fluent verbal and written English required
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment
- Is customer-service focused in approach to work, both internally and externally
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach