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The Senior Clinical Research Associate (Senior CRA) oversees the conduct of clinical trials at assigned trial sites, within the agreed time-scale, by regular monitoring. The Senior CRA may be the primary contact between the trial site and Veristat, assists in supervising assigned regional/contract CRAs, and ensures standardized and consistent performance of assigned CRAs. On selected studies, the Senior CRA may perform Lead CRA activities as per the study contract.
As a Senior CRA You Will...
Provide input in the development and/or development of clinical trial related documents including but not limited to: Protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and initiation slide presentation.
Collaborate with the Director of Monitoring/Clinical Manager and client for feasibility assessment. Assist in identifying suitably qualified trial sites within a specified geographical area. Manage IRB submissions and approvals. Supervise shipment of study drugs and materials to the site as required. Conduct qualification, initiation, interim and close out visits and provide visit reports as per monitoring guidelines. Co-monitor the study sites with the assigned inhouse/regional CRAs as required.
Maintain required documentation in the Investigator File/Regulatory Binder and provide required documentation to the clinical team/client for the Trial Master File. Maintain study specific tracking tools. Ensure the trial site complies with the study protocol, GCP and applicable regulatory requirements.
Control the integrity of the data produced by trial sites through review of case report forms, source documents/medical and pharmacy records. Ensure review is conducted in accordance with the agreed study timelines.
Verify patient eligibility, communicate and document protocol violations, non-compliance and poor performance and assure that corrective action is taken, after discussion with the Senior CRA/ Director of Monitoring and/or PM within the timeframe appropriate to the degree of deviation from the study protocol.
Liaise with the Safety PM in the management of serious adverse events and SAE reports, and ensure appropriate action is taken at the trial site in accordance with the appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations.
Provide trial site updates to the PM and/or Director of Monitoring according to study specific monitoring guidelines.
Attend Project Meetings and teleconferences as per monitoring guidelines. Attend and present at Investigator Meetings. Manage and track investigator invoices and liaise with client on any issues that may evolve.
Assist in managing investigational product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates. Assist trial sites in meeting project timelines, and proactively inform the PM and team of corrective action, as necessary. Assist in the preparation for site audits and inspections and participate in the inspections and in responding to any issues identified within the timeframe specified.
Maintain/develop a good level of scientific knowledge within the Project’s therapeutic area. Maintain good communication between study site, clinical team and client.
Experience + Requirements
Bachelor’s degree (or equivalent) in a science or healthcare-related field required. Master’s or other advanced degree preferred.
5 years of CRA experience
Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment.
A good understanding of CROs from an in-sourcing perspective. Excellent knowledge of clinical pharmacology from Phase I – IV.
Proficient in e-CRF, IVRS, and project management tools.