Clinical Trial Associate

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.