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Jobs · Analyst · Massachusetts

Clinical Trial Associate, Clinical Operations, Infectious Disease

BioSpace · Cambridge, MA · 1 wk ago
Analyst$74k–$118k/yrFull-time

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 Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) 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
  • Absorb and track 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

  • 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

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.

Our Working Model

We are focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Equal Opportunities

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants regardless of criminal histories, religious beliefs, 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. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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