Clinical Trial Associate
Primary Location: Poland, Remote Job ID R0000034972 Category Clinical TrialsAbout this Role
Clinical Trial Associate (CTA) is responsible for providing logistical support to one or more study teams through all phases of clinical study management (Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
This role is decentralised from Poland.
Key Accountabilities:
• Provides logistical support to one or more global study management teams (SMT):
- Develops and maintains effective working relationships with SMT members, affiliate team members, and vendors
- Assists Clinical Trial Manager (CTM) with effective communication between the SMT and Affiliates
- Coordinates the management of all global supplies utilizing the designated systems in collaboration with the CTM throughout the course of the study
- Coordinates and organizes study related meetings in collaboration with the Clinical Program Leader (CPL) and CTM including the development and production of presentation materials
- Consolidates study information for study trackers and databases
- Supports the protocol feasibility, country, and site selection process
- Supports CTM in technical and logistical study processes.
• Tracks and maintains study information and documentation and reports on study progress:
- Maintains accurate tracking and reporting of Study Management data
- Coordinates and maintains the contact details of core SMT and Clinical Operations teams, including country contacts and distribution lists
- Oversees the timely tracking of Health Authority (HA)/IRB/IEC submissions and approvals in CTMS. Identifies any delays and raises issues to the CTM and appropriate Country Study Manager (CSM)
- Provides IRB/IEC and HA submission documentation and all other supplementary documentation to affiliates or Product Development Regulatory (PDR), as appropriate
•Maintains and ensures the completeness of the Study-Level Trial Master File (TMF) in accordance with SOP requirements under the direction of the CTM
• Identifies and contributes to areas of best practice and process improvements. Proactively incorporates learnings and recommendations from other study debriefs and best practices.
Skills:
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
• Self-motivated and resourceful; move actions forward without the need for continual supervision
• Maintain a strong knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable Parexel procedures and Client specific procedures.
• Good oral and written communication skills to internal and external customer.
• Ability to prioritize multiple tasks and achieve project timeline.
• High commitment to and performs consistently high-quality work.
• Effective problem-solving skills.
• Mentor and train less experienced staff as appropriate.
• Active participant as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight.
• Fluent English and Polish skills (oral and written).
Knowledge and Experience:
• Experience in office management in an international environment would be advisable.
Education:
• Relevant qualification or equivalent experience required.
• High school diploma – ideally degree in life science or other related background – preferred.
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