In-House Clinical Research Associate (CRA) Sage Therapeutics 2 reviews - Cambridge, MA 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 * Provide overall tactical support for the study * Provide administrative support, as needed, for one or more studies * Identify and resolve project administration issues

• Lead or assist with TMF processes: set-up, training, QC, management * Collaborate with CRO counterpart * Provide study support and systems management * Review ICFs * Proactively identify and solve study-related issues * Track clinical supply shipments and manage shipment logistics * Participate in IM planning and conduct * Coordinate vendor face to face meetings * Provide documentation for CSR appendices * Provide monthly site activation updates to Regulatory for routine IND submission updates
• Track/manage translations of recruitment materials and questionnaires
• Obtain questionnaire/scale licenses with support from Study Manager and HEOR Experience, Education and Specialized Knowledge and Skills * BS/BA degree or equivalent and 2+ years experience in clinical development and operations with 3+ years strongly preferred * On-site monitoring experience conducting SIVs, IMVs, and COVs required. * 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. 13 hours ago - save job

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