Clinical Trial Associate, Clinical Operations

About the role

The Clinical Trial Associate (CTA) provides clinical trial coordination support to project teams for assigned clinical trials. 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.

Responsibilities

• Aid 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.
• Cook up project team and departmental meetings, including preparation and maintenance of meeting documentation and action items.
• Aid 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.

Requirements

• 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.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities in a fast-paced environment.
• Self-motivated, adaptable, and eager to learn.
• Demonstrated ability to collaborate effectively across functions and with external partners.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs. A holistic approach to well-being, with access to fitness, mindfulness, and mental health support. Family planning benefits, including fertility, adoption, and surrogacy support. Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown. Savings and investments to help you plan for the future. Location-specific perks and extras.

Schedule

The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Benefits

Competitive healthcare, plus voluntary benefit programs to support your unique needs.
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
Family planning benefits, including fertility, adoption, and surrogacy support.
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
Savings and investments to help you plan for the future.
Location-specific perks and extras.

Moderna

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.