Clinical Trial Assistant – Premier Research – 서울

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 Assistant 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.

You’ll be doing:

The Clinical Trial Assistant (CTA) supports the Clinical Research Associate (CRA) within the Clinical Data Sciences department by assisting in the administrative organization and management of projects, ensuring compliance with Premier Research SOPs, Sponsor SOPs and ICH-GCP/ISO14155 and local requirements .CTA assists with site communication, issue/query resolution, document management, tracking and archiving on multiple clinical trials.

• Assists CRAs with regular site communication and its documentation according to CMP and any other internal and external communication
• Supports the CRA in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment
• Assists CRA in audit/inspection preparation activities
• Creates, reviews and updates Investigator/Pharmacy site files in collaboration with the study team before SIV
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the CRA as defined by the organization’s processes per filing guidelines. Understands the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates. Performs QC of relevant eTMF sections during all study phases
• Assists the clinical study team in distribution of mailings, documents (also hard copies) and other study materials to sites and others as appropriate.
• Supports CRA in the query resolution process with sites and Premier Research Data Management, if necessary
• Assists CRA with study-related payment processing
• Supports the translation of site documents or reviews translations of site documents, if required
• Assists CRAs with submission of expenses according to travel and expense requirements within company guidelines (depending on country location)
• Supports CRA with on-site activities, if applicable
• Attends meetings as required
• Completes all required internal training (general and study-specific) on-time
• Performs additional duties and assignments as required
• May be involved in general office logistical activities as requested

You’ll Need:

• Undergraduate degree or its international equivalent in nursing, life sciences or medical documentation

• Fluent verbal and written English
• Knowledge of ICH/GCP preferred
• Solid computer knowledge/skills including MS Word, Excel, PowerPoint and Outlook
• Excellent interpersonal and listening skills
• Ability to work independently as well as part of a team
• Excellent organizational and time-management skills, able to prioritize work to meet deadlines