Covance is looking for a Senior CRA with at least 4 years of monitoring in the UK to be client dedicated with one of key customers.
Investigative site management and monitoring
Demonstrate commitment to quality in all aspects of monitoring; ensure ethical conduct of clinical studies; adhere to study monitoring instructions/conventions, write reports within the timeframe agreed at study start, conduct Feasibility assessment, Site Selection Visit, Site Initiation Visit, Monitoring Visits and Close-Out visit at investigative sites; regular review of Investigator Site Files and ensure that the ISF reconciliation with the Trial Master File is conducted; ensure proper handling of study drugs; perform study drugs accountability; ensure site inspection readiness; ensure site performance (recruitment) as planned; monitor and track the informed consent process; perform safety reviews/SAE reconciliation and assure appropriate action is taken at the investigative site in accordance with the appropriate policies and SOPs, as well as ICH-GCP guidelines and local regulations.
Conduct Source Document Verification of CRF data against medical records/pharmacy records, etc. to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with Clinical Development Data Management in order to improve data quality; ensure issues relating to data quality are escalated and resolved with the study team
Attend CRA and Investigator meetings; if required, assist with training of investigative site personnel in GCP and local regulations and ensure sites are conducting Actelion’s clinical research according to the protocol, local regulatory requirements and other appropriate regulations; build relationships with site staff at assigned sites. Assist in the preparation for site audits and inspections and in responding to any issues identified within the timeframe specified.
Identify site issues and ensure resolution, escalating issues if necessary; create and submit monitoring reports within the timeframe agreed at study start, confirmation/follow-up correspondence and telephone contacts for assigned sites and send documents to study team as required; respond to audit findings; adhere to proper lines of communication attend and participate in study team meetings/teleconferences as well as country meetings/teleconferences; ensure information in the CTMS is up to date
Keep medical and clinical knowledge for assigned therapeutic areas up to date; mentor/coach new CRAs; maintain annual training records
Collecting regulatory documentation (when required), maintain required documentation in the Investigator Site File and provide required documentation from site for the Trial Master File according to quality standards.
Support in responding to company, client and federal regulatory requirements/audits