Clinical Trial Associate, Clinical Operations at Moderna

About This Role

he Role

The Clinical Trial Associate (CTA) provides clinical trial coordination support to project teams for assigned clinical trial(s). This support includes tracking a wide range of key operational activities and maintaining essential study documentation, including the electronic Trial Master File (eTMF). This position works closely with internal team members, external vendors, CROs, and clinical sites to support the successful execution of clinical studies. The CTA will collaborate cross-functionally to ensure clinical operations activities are conducted efficiently, compliantly, and in alignment with study objectives. Successful candidates may be aligned to support clinical programs in Infectious Disease, Oncology, or other therapeutic areas based on business needs and experience.

Here's What You'll Do

Assist Clinical Operations Leads (COLs) and/or Clinical Trial Managers (CTMs) with the day-to-day operational activities of assigned clinical trials to ensure study objectives and timelines are met with quality and in compliance with applicable SOPs and regulatory guidelines.
Maintain clinical trial files (including eTMF), project processes, tracking systems, and other study or departmental systems.
Liaise with Clinical Sample Management to support the tracking and coordination of biomarker and clinical sample testing with external laboratories.
Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to clinical systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders, including CRO personnel and clinical site staff.
Coordinate project team and departmental meetings, including preparation and maintenance of meeting documentation and action items.
Assist with vendor and clinical site agreements, budget tracking, purchase order management, invoice reconciliation, and related operational activities.
Develop and maintain strong, collaborative relationships with internal stakeholders, CROs, vendors, and clinical sites.
Support inspection readiness activities and contribute to continuous process improvement initiatives within Clinical Operations.

Here’s What You’ll Need (Basic Qualifications)

Minimum of 2 years of experience in a clinical research or clinical operations environment.
Bachelor's degree in a science-related discipline preferred.
Basic understanding of drug development and clinical trial conduct, including familiarity with FDA regulations, ICH-GCP guidelines, and industry best practices.
Strong verbal and written communication skills.

Clinical Trial Associate, Clinical Operations

About This Role

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