Senior Clinical Trial Associate

Overview

• Support late-stage cardiovascular clinical programs as a Senior Clinical Trial Associate.
• Collaborate with clinical trial teams to ensure compliance with regulations and guidelines.
• Assist in managing clinical studies from startup through database lock.
• Contribute to vendor oversight and budget management for clinical trials.
• Prepare, edit, and track essential clinical documents and study materials.
• Perform quality control reviews of Trial Master Files and ensure compliance.
• Coordinate with cross-functional teams for site activation and study operations.
• Support registry updates and system maintenance for clinical trial information.
• Contribute to the development of presentations and reports for trial stakeholders.

Key Responsibilities & Duties

• Coordinate and track trial activities to ensure protocol compliance and regulatory adherence.
• Capture and follow up on action items from internal and external team meetings.
• Oversee CROs and third-party vendors to meet study requirements and timelines.
• Review vendor invoices for accuracy and track payments against budgets.
• Assist in preparing and reviewing clinical protocols, informed consents, and study manuals.
• Participate in the development and testing of EDC and IRT systems.
• Perform periodic reviews and quality control of Trial Master Files.
• Coordinate essential document reviews for site activation with clinical and regulatory teams.
• Support planning and execution of Investigator Meetings and study-related presentations.

Job Requirements

• Bachelor’s degree in life sciences or healthcare-related discipline required.
• Minimum of 4 years of clinical research support experience; 7 years preferred.
• Proficiency in Good Clinical Practice (GCP) and ICH guidelines.
• Strong communication skills and ability to work collaboratively in team environments.
• Experience with Trial Master Files and quality control processes.
• Proficiency in Microsoft PowerPoint, Excel, Word, and Smartsheet.
• Analytical thinking and problem-solving skills with adaptability to changing priorities.
• Ability to manage multiple projects and prioritize effectively.
• Willingness to travel as required for clinical trial activities.