Clinical Trial Associate

Manages administrative support and tasks for the Clinical Project Team, including but not limited to filing, faxing, memos, letters and photocopying support for designated project team(s), as required; prepares study documents at the direction and oversight of the Project Prepares documents for and distributes various investigator, regulatory, operations, guidelines and training manuals
Assists in the preparation of conference calls, meetings, and conferences by developing agendas, coordinating participation, preparing and distributing materials, summarizing proceedings and tracking follow-up actions. Preparing reports, tables and data analysis for incorporation into broader documents and reports. Organize and maintain paper and electronic archived records of all committee business, correspondence and reviews

QUALIFICATIONS:

- University degree (Preferable life science)
- A minimum of 1 year experience in clinical research or healthcare related industry
- Knowledge of ICH/GCP
- Proficient computer skills across multiple applications
- CRO, Pharmaceutical, Biotech, experience preferred

RESPONSIBILITIES:

- Performs job duties with minimal guidance.
- Communicates with sites regarding trial start-up, conduct, and close-out activities
- Collects and reviews regulatory documents from clinical sites
- Initiates, maintains, and reconciles Trial Master File
- Organizes and maintains tracking systems and tools to support the conduct of a clinical study from start-up to close-out.
- Manages and tracks clinical/non-clinical supplies

SKILLS:

- Effective English written and verbal communication skills
- Well organized and focus on details
- Prioritizes and multitasks to ensure that tasks are completed on time
- Effectively collaborates with team members

WE OFFER:
- Excellent working conditions
- Training
- Competitive salary & benefits package;
- Opportunities for personal & professional growth.

Premier Research is a leading global solutions-driven CRO committed to therapeutic focus and operational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies and has clinical operations teams in more than 30 countries.