Senior Clinical Trial Associate

Role Summary

The Senior Clinical Trial Associate (CTA) supports the operational execution of clinical trials from start-up through close-out. This role partners closely with Clinical Trial Leaders, study teams, CROs, and vendors to ensure trials are conducted efficiently, compliantly, and in alignment with program and company objectives.

Responsibilities

• Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
• Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
• Collect, track, and review investigator site regulatory documentation for completeness and accuracy.
• Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH-GCP and company SOPs.
• Track and maintain essential study documentation, including CTA and budget status, site and vendor payments, monitoring visits and reports, SUSARs, CAPAs, and enrollment metrics.
• Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
• Ensure clinical trial management systems are kept current in collaboration with the Clinical Trial Leader (CTL).
• Support study start-up, conduct, monitoring, and close-out activities to ensure protocol adherence and regulatory compliance.
• Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
• Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
• Provide operational and financial support, including purchase orders, contract setup, invoice processing, and tracking of study budgets.
• Assist with development, review, and maintenance of study documents (e.g., protocols, ICFs, CRFs, monitoring plans, manuals).

Qualifications

• Required: Requires a bachelor’s degree in a scientific field plus substantial relevant professional experience in clinical trial management or related clinical research position (4 years or equivalent).
• Required: Ability to mentor and coach junior or new staff.
• Required: Advanced knowledge of medical and trial-related terminology; excellent administrative and coordination skills.
• Required: Excellent communication skills (verbal and written) and proficiency with MS Office, Outlook, and TEAMS; English proficiency.
• Required: Excellent time and priority management; ability to work efficiently under pressure.
• Required: Thorough understanding of Clinical Operations policies, ICH-GCP, and FDA regulations; proficient Trial Master File experience with eTMF systems.
• Required: Strong organizational and problem-solving skills; willingness to take on responsibility and exhibit leadership.
• Required: Ability to travel based on assigned study needs (typically minimal travel).

Skills

• Excellent administrative and coordination skills
• Excellent communication skills, both verbal and written
• Strong organizational and problem-solving abilities
• Proficiency with MS Office (Excel, Word, PowerPoint), Outlook, and TEAMS
• Ability to work in a matrix environment and collaborate across functions

Education

• Bachelor’s degree in a scientific field

Additional Requirements

• Ability to travel based on assigned study needs (typically minimal travel)