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Clinical Trial Associate, Clinical Operations, Infectious Disease

Company: ModernaTX, Inc.
Location: Cambridge
Posted on: September 25, 2022

Job Description:

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 Bring to the Table:
    • 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

      Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
      • Highly competitive and inclusive medical, dental and vision coverage options
      • Flexible Spending Accounts for medical expenses and dependent care expenses
      • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
      • Family care benefits, including subsidized back-up care options and on-demand tutoring
      • Free premium access to fitness, nutrition, and mindfulness classes
      • Exclusive preferred pricing on Peloton fitness equipment
      • Adoption and family-planning benefits
      • Dedicated care coordination support for our LGBTQ+ community
      • Generous paid time off, including:
        --- Vacation, sick time and holidays
        --- Volunteer time to participate within your community
        --- Discretionary winter shut down
        --- Paid sabbatical after 5 years; every 3 years thereafter
      • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
      • 401k match and Financial Planning tools
      • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
      • Complimentary concierge service including home services research, travel booking, and entertainment requests
      • Free parking or subsidized commuter passes
      • Location-specific perks and extras!
        Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

        About Moderna

        In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

        Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

        Moderna is a smoke-free, alcohol-free and drug-free work environment.

        Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
        #LI-TR2
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Keywords: ModernaTX, Inc., Cambridge , Clinical Trial Associate, Clinical Operations, Infectious Disease, Healthcare , Cambridge, Massachusetts

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