Clinical Research Associate

beigene; España; Presencial; EUR 41.000 - 52.000; Jornada completa

Descripción de la vacante

BeOne is seeking a Clinical Research Associate (CRA) to monitor oncology/hematology trials across the region, ensuring adherence to ICH-GCP, local regulations and SOPs. You will perform feasibility, site identification, initiation, routine monitoring and closeout visits, while maintaining study timelines and quality.

Responsibilities include coordinating with the Regional Clinical Operations Manager, supporting site training, and driving CAPA where needed.

Formación

• Science degree required.
• Master in Monitoring and Management of Clinical Trials preferred.

Responsabilidades

• 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).
• Establish regular lines of communication with sites and report site progress, issues and proposed actions.

Educación

Sciences degree

Master in Monitoring and Management of Clinical Trials

Herramientas

MS Word

Excel

MS Project

MS PowerPoint

Outlook

Descripción del empleo

BeOne 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

Essential Functions of the job:

• 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

Education Required:

• Sciences degree
• Master in Monitoring and Management of Clinical Trials

Supervisory Responsibilities:

N/A

Computer Skills:

Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

Travel: Yes

Salary Range EU:

41,400.00 EUR - 51,800.00 EUR

Global Competencies

• 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

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.