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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