General Description
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.
Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology / hematology clinical trials within the assigned region.
The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
Identify gaps and areas for improvement and propose CAPA.
Supports start-up and provides local expertise.
SSU experience is considered a plus
CRA activities
Perform feasibility, site identification, selection and evaluation, 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 visits per monitoring plan and applicable SOPs
Conducts co-monitoring visits, if required
Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines 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 Regional Clinical Operations 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 Study Oversight Visits (SOVs), 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.
Education Required :
BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
Experience in oncology global trials preferred
Other Qualifications :
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
Experience in oncology / hematology trials preferred
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Fluent in English & Italian (writing and speaking)
Computer Skills : Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel : up to 60%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
* Fosters Teamwork
* Provides and Solicits Honest and Actionable Feedback
* Self-Awareness
* Acts Inclusively
* Demonstrates Initiative
* Entrepreneurial Mindset
* Continuous Learning
* Embraces Change
* Results-Oriented
* Analytical Thinking / Data Analysis
* Financial Excellence
* Communicates with Clarity
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