[Hiring] Clinical Research Associate I @BeiGene

Role Description

The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country. The CRA is responsible for delivering data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.

• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if required
• Conducts co-monitoring visits, if required
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Attends onboarding, disease indication and project specific training and general CRA training as required
• Documents monitoring activities appropriately following ICH-GCP and BeOne standards
• Conducts Quality Oversight Visits (QOV), as requested
• Completes monitoring visit/ QOV reports timely
• Assists with investigator/site identification
• Assists site to prepare Ethics Committee submissions
• Facilitates clinical trial site contract and budget negotiation
• Manages site queries and communications
• Assists in managing clinical trials, if required
• Establishes regular lines of communication with sites and COMs
• Provides protocol and related study training to assigned sites
• Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
• Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
• Performs additional tasks as assigned

Qualifications

• At least 2 years of Clinical Research Coordinator experience in Oncology
• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English (writing and speaking)

Requirements

• Early Phase Preferred
• Hematology and Solid Tumor Experience Preferred
• Up to 70% travel - multi regional

Education Required

• Bachelor’s degree or above in life sciences, pharmacy, nursing or medical

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

Salary Range

$80,000.00 - $105,000.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. The Company has a comprehensive benefits package that includes opportunities for equity awards and participation in the Employee Stock Purchase Plan.

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.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].