Clinical Research Associate

• 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%