Clinical Trial Associate, Clinical Operations, Infectious Disease at Moderna

About This Role

The 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 maintenance of essential study documentation, including the electronic Trial Master File (eTMF). This position will work with internal team members and with external vendors and CROs. The position reports to the Clinical Operations Head in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinical operations activities.

Here’s What You’ll Do

Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems
Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs
Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
Coordinate Project Team and departmental meetings, including associated documentation
Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
Develop and maintain strong, collaborative relationships with key stakeholders within Moderna, its CROs, and clinical sites

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

At least 2 years of experience in a clinical research environment
Bachelor’s degree in a science-based discipline preferred
Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Good verbal and written communication skills
Good organizational skills and attention to detail
Willingness to learn, able to take direction and ability to manage multiple tasks
Self-motivated and comfortable with shifting priorities and change in a small company environment

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.

Clinical Trial Associate, Clinical Operations, Infectious Disease

About This Role

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