Clinical Research Associate

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.
• 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, 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 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.

Senior responsibilities:

• Mentor and manage junior staff and Clinical Research Associates
• Acts as the escalation point person for CRA(s) with site related issues and concerns
• May review visits reports, following-up on issue resolution and communicating with the Regional Clinical Operations Manager on significant risk identified and action proposed
• May serve as subject matter expert for clinical operations, country regulations and monitoring related activities.

Education Required:

• BS in a relevant scientific discipline and minimum of 2 year 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
• 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)

Travel: up to 60%