Regional Senior CRA EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Position Summary
The Regional Sr. Clinical Research Associate (US Central to West location) provides clinical trial operational site support including all processes related to study start-up and site management through close-out, assuring GCP and ICH practices and compliance. A qualified Senior Clinical Research Associate will conduct and document site initiation visits, interim visits, co-monitoring visits and close-out visits. Expected to serve as lead CRA on trials as assigned, providing monitoring expertise and driving the site and monitoring related activities for the trial. Expected to serve in Clinical Monitoring Liaison role where monitoring is outsourced, providing monitoring expertise for trial teams and serving as a liaison for sites, CRO and the trial team. In this role, the SrCRA conducts co-visits with the CRO monitor and reviews monitoring reports provided by Contract Research Organization (CRO).
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions
Conducts on-site qualification, initiation, interim monitoring visits, and site closure visits of all phases of clinical trials
Reviews study data for completeness, accuracy and consistency with study protocol and investigator's records
Interfaces with clinical sites/investigators on-site and through administrative site management to ensure compliance with protocols and regulatory compliance
Prepares and tracks required documentation from clinical sites
Serves as primary contact for clinical site personnel for addressing routing questions regarding the execution of the protocol and subject eligibility
May assist in the development and review of case report forms, monitoring plans and other relevant clinical trial documents.
Participates in in-house and/or external training and educational opportunities to build expertise and monitoring skills
Expected to serve as lead CRA on trials as assigned, providing monitoring expertise and driving the site and monitoring related activities for the trial.
Expected to serve in Clinical Monitoring Liaison role, providing monitoring expertise for trial teams and serving as a liaison for sites, CRO and the trial team.
Conducts co-visits with CRO monitor, reviews monitoring visit reports and acts as liaison between trial sites, CROs and EnVivo when trials are outsourced to vendors.
Bachelor's degree in a scientific discipline, RN or BSN degree or equivalent;
5-10 years previous CRA experience
Strong interpersonal skills, exceptional organizational and time-management skills, and oral and written
communication skills are essential
Knowledge of local regulatory requirements
Capable of working on clinical monitoring issues of complicated scope
Exercises judgment on routine clinical procedures and practices to determine appropriate action
Generally receives instructions on routine work and detailed instruction on new assignments and can execute with minimal oversight.
Must be willing to travel (50% of time)
Proximity to major airport
Has valid driver?s license
Experience managing or overseeing work by CROs/vendors would be a plus
||Watertown, MA |
THIS JOB HAS EXPIRED