Clinical Trial Associate Jobs

Description

The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s). This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). This position will work with internal team members and with external vendors and CROs. The position reports to the Clinical Operations Head in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinical operations activities.

Here’s What You’ll Do:

• Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
• Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to internal systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
• Develop and maintain strong, collaborative relationships with key stakeholders internally as well as with its CROs, and clinical sites
• Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
• Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems
• Coordinate Project Team and departmental meetings, including associated documentation
• Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs

Here’s What You’ll Bring to the Table:

• Good verbal and written communication skills
• Willingness to learn, able to take direction and ability to manage multiple tasks
• Bachelor’s degree in a science-based discipline preferred
• Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Self-motivated and comfortable with shifting priorities and change in a small company environment
• At least 2 years of experience in a clinical research environment
• Good organizational skills and attention to detail