Clinical Trial Associate, Clinical Operations, Therapeutics and Oncology

ModernaCambridge, MA
$74,000 - $118,400Onsite

About The Position

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), 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.

Requirements

  • 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

Responsibilities

  • 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

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 investment opportunities to help you plan for the future
  • Location-specific perks and extras
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