Clinical Research Associate - North of Italy

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 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.

• 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.

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 3 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)

Education Required:

• BS in a relevant scientific discipline and minimum of 3 years of monitoring experience.

• Experience in oncology global trials preferred

Travel: up to 60%

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - B