The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
May be assigned to CRA activities or start-up activities, depending on experience and project needs
Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
Identify gaps and areas for improvement and propose CAPA.
Supports start-up and provides local expertise.
Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets
Provides protocol and related study training to assigned sites.
Conducts monitoring (pre-study, initiation, routine monitoring and closeout) visit per monitoring plan and applicable SOPs
Conducts co-monitoring visits, if required
Completes monitoring visit reports in accordance with ICH-GCP, BeiGene standards and SOP
Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
Ensure inspection readiness of the study and sites
Collaborates with Clinical Study Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
Attends disease indication project specific training and general CRA training as required
Facilitate Site Compliance Visits (SCVs), site audits and/or inspections, as required
Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Qualifications
BS in a relevant scientific discipline and minimum of 1 years of monitoring experience.
Experience in oncology global trials preferred
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook Other Qualifications
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
2-5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry preferred
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Fluent in English and Dutch (writing and speaking)
