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.