Clinical Trial Associate

About the role

This role supports the Clinical Trial Manager and broader clinical operations team by coordinating daily study operations and execution activities across assigned clinical trials. The Clinical Trial Assistant maintains high-quality documentation, supports site and vendor management, and helps ensure that all clinical trial activities align with regulatory requirements, internal procedures, and project timelines.

Responsibilities

• Support the Clinical Trial Manager with day-to-day study operations and execution activities across assigned clinical trials.
• Maintain, review, and organize Trial Master File (TMF) and electronic Trial Master File (eTMF) documentation to ensure completeness, accuracy, and inspection readiness.
• Track study timelines, deliverables, action items, and key milestones, and escalate potential risks or delays to the appropriate stakeholders.
• Cook up meetings with internal teams, contract research organizations (CROs), vendors, and study sites, including preparing agendas, recording minutes, and tracking follow-up actions.
• Aid with study start-up activities by collecting regulatory documents, supporting site activation readiness, and organizing investigator documents and essential study records.
• Serve as a primary point of contact for document requests and routine communications between internal stakeholders, CROs, and investigational sites.
• Aid with site management activities by tracking site status, enrollment metrics, training completion, and key study deliverables to ensure ongoing study oversight.
• Aid with vendor management activities, including creating and tracking purchase orders, monitoring invoices, and maintaining study-related documentation.
• Generate and maintain study trackers, reports, dashboards, and operational metrics to support effective study oversight and decision-making.
• Assist with enrollment and recruitment reporting by collecting, consolidating, and distributing study performance data to relevant stakeholders.
• Aid with database User Acceptance Testing (UAT), system access requests, and other clinical systems-related activities as needed.
• Ensure that study documentation, correspondence, and filing activities comply with standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Partner with Clinical Operations, Data Management, Regulatory Affairs, Clinical Supply, and other cross-functional teams to facilitate smooth and timely study execution.
• Support audit and inspection readiness activities by preparing documentation, organizing files, and assisting with responses to study-related requests.
• Participate in process improvement initiatives and help identify opportunities to enhance operational efficiency across clinical programs.

Requirements

• Bachelor's degree in Life Sciences, Healthcare, Nursing, or a related field.
• At least 2 years of clinical research experience within a pharmaceutical, biotechnology, or contract research organization (CRO) environment.
• Experience supporting clinical trials in a Clinical Trial Assistant, Clinical Operations Associate, or similar role.
• Experience managing and maintaining TMF and eTMF systems.
• Experience with clinical trial management systems and other clinical trial platforms.
• Working knowledge of ICH-GCP guidelines and clinical trial processes.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Excellent written and verbal communication skills.
• Proficiency with clinical systems, Microsoft Office Suite, and document management platforms.

Qualifications

• Phase 2 clinical trial experience preferred.
• Experience collaborating with Clinical Trial Managers and cross-functional study teams.
• Demonstrated ability to track study metrics, timelines, and deliverables.
• Comfort working with dashboards, trackers, and operational reports to support study oversight.

Skills

• Phase 2 clinical trial experience preferred.
• Experience collaborating with Clinical Trial Managers and cross-functional study teams.
• Demonstrated ability to track study metrics, timelines, and deliverables.
• Comfort working with dashboards, trackers, and operational reports to support study oversight.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)