Senior Clinical Research Associate - Boston, MA
The CRA, as a member of the Clinical Affairs team will participate in and may lead clinical research programs developed by the company, by assisting with the development of study protocols, case report forms, clinical reports; performing site monitoring visits, and interfacing with site coordinators, field clinical staff, Clinical Research Organizations (CRO), and other company representatives.
Responsibilities include (but not limiting):
- Ensuring documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
- Assist in the design of study protocols, case report forms, consent forms for sound and thorough data to support the product through the approval process
- Review study records including case report forms, consent forms, and other materials
- Assist site coordinators, investigators, field clinical staff, CRO (as applicable)in collecting data in a timely manner that meets protocol requirements
- Organize data in systematic manner to allow for efficient and accurate clinical reports
- Review, reconcile, and maintain Trail Master Files for multi-center, multi-national clinical trial(s)
- Perform pre-qualification, site initiation, routine monitoring and site close-out visits and conduct co-monitoring visits with CRO staff at participating sites
- Serve as a resource to site coordinators, investigators, and other staff members regarding protocols.
- Assist in writing the clinical study reports as well as the clinical portion of Regulatory submissions
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities
- Oversees delivery and shipment of products required to conduct clinical investigations
- Maintain in-house study trackers (enrollment, screening, start-up progress, etc.)
- Process and track study site payments and vendor payments
If you or a Senior Clinical Research Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.