Sage Therapeutics

  • In-House Clinical Research Associate (CRA)

    Job Locations US-MA-Cambridge
    Posted Date 1 month ago(1 month ago)
    ID
    2018-2320
    # of Openings
    1
    Category
    Clinical
  • Overview

    General Scope and Summary

    Sage Therapeutics is searching for a resourceful, confident, professional with on-site monitoring experience for an important role as an In-House CRA working on several fast-moving studies for one of our lead programs in the CNS space.  The In-house CRA will provide support to study management tasks in collaboration with the Study Manager and/or Senior Managers, with an emphasis on leading monitoring oversight activities for our clinical CROs.

    Roles and Responsibilities

    • Assist the Study Manager in training CRO CRAs and creating the CRA training material
    • Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed
    • Review Monitoring Visit Reports from the CRO
    • Monitor studies (PSV, SIV, IMV, COV) as needed
    • Escalate monitoring trends or findings to the Study Manager
    • Track metrics related to Sponsor Oversight and the Monitoring Plan
    • Assist in start-up activities of clinical research studies including Investigator Meetings, enrollment planning, and Investigator selection
    • Collaborates closely with Sage study management, CRO study managers, and CRO monitoring staff, reviews site/patient activity tracking, prepares study updates and proactively identifies and solves study-related issues
    • Regularly communicates with Investigators to identify and resolve complex clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements;
    • Guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability;
    • Reviews and provides input to study plans and guidelines, including study monitoring plans;
    • Assists in development of study documents, such as informed consent forms, study logs, and study manuals
    • Provide overall tactical support for the study
    • Lead or assist with TMF processes: set-up, training, QC, management
    • Collaborate with CRO counterpart

     

    Experience, Education and Specialized Knowledge and Skills

    • BS/BA degree or equivalent and 4+ years experience in clinical development and operations
    • At least 2 years experience performing on-site monitoring conducting SIVs, IMVs, and COVs for IND regulated clinical research studies.
    • Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
    • Demonstrated effectiveness in resolving site management issues of varying complexity
    • Co-monitoring experience required
    • This role will require some travel – ranging from 10% - 50% during peak study activity
    • Strong communication and interpersonal/team skills
    • Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
    • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
    • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of Sage.

     

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