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%).