Clinical Research Associate

BeOne Medicines; España; On-site; PHP 3,007,000 - 3,762,000; Full time

Job summary

BeOne Medicines in Europe seeks an experienced Clinical Research Associate to monitor oncology/hematology trials at sites, ensuring compliance with ICH-GCP and local regulations and maintaining data quality.

You will collaborate with the Regional Clinical Operations Manager, perform feasibility and site identification, provide training, conduct monitoring visits, and drive CAPA and improvements while traveling as required.

Qualifications

• Sciences degree required.
• Master in Monitoring and Management of Clinical Trials required.
• Experience with ICH-GCP guidelines and monitoring activities.
• Ability to train site staff on protocols and procedures.
• Willingness to travel to trial sites as needed.

Responsibilities

• Perform feasibility, site identification, selection and evaluation for trials.
• Provide protocol and study training to assigned sites.
• Conduct monitoring visits per plan and SOPs (pre-study, initiation, routine, closeout).
• Manage site performance by tracking submissions, recruitment, CRF completion, data queries.
• Ensure inspection readiness and timely delivery of study milestones.

Skills

Clinical Monitoring

ICH Guidelines

GCP

CAPA

Travel readiness

Education

Sciences degree

Master in Monitoring and Management of Clinical Trials

Tools

MS Word

MS Excel

MS Project

MS PowerPoint

Outlook

Job description

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

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

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.