Job Summary:
Senior Clinical Research Associate
The Senior Clinical Research Associate position will include monitoring responsibilities, on-site training and in-house study management activities.
Responsibilities of the Senior Clinical Research Associate include but are not limited to:
- Monitoring and site management activities (pre-study site evaluations, site initiation, interim site monitoring, and closeout visits).
- Travel to clinical sites and meetings to initiate/monitor/train site staff for clinical studies, ensuring appropriate documentation and reports are maintained (e.g., regulatory files, case report forms, and source documents are in order). Travel expectations are 50 – 75%, but may vary based on study needs.
- Collaborate with study team and site/CRO to identify and resolve outstanding issues and data queries, documenting as appropriate
- Review study progress with investigators and coordinators, determining and monitoring time schedules as well as adherence to clinical study protocol.
- Prepare monitoring reports confirmation and follow up letters in accordance with plans.
- Pre-study qualification of investigators/site for clinical trials
- Collaborate with otherinernal team members (Clinical Project Coordinators and Clinical Trial Assistants)
- Start-up of multi-center trials: regulatory document collection and review, study document/materials collation and distribution
- Effective communication between site staff, sponsor, internal staff members
- Participate in project team meetings
· May include project work where site activities are slow (e.g. Plan writing, tracking of documents, training, study related start up activities, site identification, creation of study related documents)
- Knowledge of FDA/GCP regulatory requirements
- Knowledge of Excel, Word and Powerpoint, Electronic Data Capture systems, CTMS, eTMF systems
- Ability to work on multiple activities concurrently
· 5 or more years in a CRA role
· 2 or more years of cardiovascular study experience (device, pharma and biologics)
Background in nursing or other clinical field is preferred
Pay: $75.00 - $125.00 per hour
Medical Specialty:
Ability to Commute:
- Boston, MA 02111 (Required)
Ability to Relocate:
- Boston, MA 02111: Relocate before starting work (Required)
Work Location: Hybrid remote in Boston, MA 02111
