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.