Clinical Trial Associate

Essential Functions and Responsibilities

• Support the day-to-day execution of clinical trials from study start-up through closeout.
• Assist Clinical Trial Managers with operational study activities and project coordination.
• Coordinate study team meetings, prepare agendas, document meeting minutes, and ensure follow-up on action items.
• Maintain study trackers, timelines, enrollment reports, and operational dashboards.
• Assist with site onboarding and activation activities.
• Support management of CROs, vendors, and study-related deliverables.
• Maintain electronic Trial Master Files (eTMFs) to ensure completeness, quality, and inspection readiness.
• Conduct routine TMF reviews and reconcile missing or incomplete documents with CROs and study vendors.
• Assist with collection, review, filing, and archiving of essential trial documents.
• Maintain study-specific filing systems and operational documentation.
• Support study start-up activities including vendor onboarding, site activation, investigator meetings, and study system setup.
• Assist with review and distribution of study materials, informed consent documents, and study tools.
• Coordinate clinical trial supplies, equipment shipments, and study-related materials.
• Track regulatory submissions, site essential documents, and study milestones.
• Serve as an operational point of contact for clinical sites, CROs, and other external partners.
• Facilitate communication between internal teams and external stakeholders.
• Track site and vendor inquiries and route issues to appropriate team members.
• Assist with scheduling vendor meetings and maintaining documentation of vendor performance activities.
• Ensure clinical trial activities are conducted in accordance with ICH/GCP guidelines, applicable regulations, and internal SOPs.
• Support audit and inspection readiness activities.
• Assist with quality review of study documentation and study-level processes.
• Participate in process improvement initiatives across Clinical Operations.
• Support study closeout activities, including TMF reconciliation, site document collection, and archiving activities.
• Assist with drug accountability reconciliation and study documentation required for Clinical Study Reports (CSRs).
• Perform other duties as assigned.

Required Education, Experience, Skills, and Abilities

• Bachelor's degree in Life Sciences, Nursing, Public Health, or a related scientific discipline.
• 2+ years of clinical research experience in a pharmaceutical or biotechnology setting.
• Experience supporting Phase I-IV clinical trials.
• Experience supporting autoimmune, immunology, or oncology clinical trials preferred.
• Working knowledge of ICH/GCP guidelines and applicable clinical research regulations.
• Experience maintaining clinical trial documentation and/or Trial Master Files (TMFs).
• Familiarity with clinical systems such as eTMF, CTMS, EDC, IRT, or related platforms.
• Strong organizational skills and exceptional attention to detail.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
• Demonstrated ability to work collaboratively across cross-functional teams.
• Ability to work independently in a fast-paced environment while appropriately escalating issues.
• Minimal travel required (0-10%).