Clinical Research Associate I (CRA I) - Oncology

BeiGene

3d • $80,000 - $105,000

About The Position

The Clinical Research Associate I performs monitoring activities for Oncology and Hematology clinical trials within the country, supporting trial initiation, conduct—including recruitment and quality data collection—and timely completion. The role is accountable for delivering data on schedule and to required quality standards, and for ensuring monitoring activities follow GCP, ICH, local regulations, and company SOPs. The position involves site monitoring and oversight, site performance management, communications and training, and collaboration with clinical research colleagues. Travel of up to 70% across multiple regions is required.

Requirements

• At least 2 years of Clinical Research Coordinator experience in Oncology.
• Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines.
• Excellent communication and interpersonal skills.
• Excellent organizational skills and ability to prioritize and multitask.
• Fluent in written and spoken English.
• Bachelor’s degree or above in life sciences, pharmacy, nursing, or medicine.
• Efficient with Microsoft Word, Excel, PowerPoint, OneNote, and Outlook.
• Familiarity with industry EMR, CTMS, site file management, and data management systems.
• Ability to travel up to 70% across multiple regions.

Nice To Haves

• Early-phase clinical research experience preferred.
• Hematology and solid tumor experience preferred.

Responsibilities

• Conduct pre-study, initiation, routine monitoring, and closeout visits when required.
• Conduct co-monitoring visits when required.
• Ensure study milestones for assigned sites are achieved as planned, including startup, recruitment, database analyses, and closeout.
• Attend onboarding, disease-indication, project-specific, and general CRA training as required.
• Document monitoring activities in accordance with ICH-GCP and BeOne standards.
• Conduct Quality Oversight Visits (QOVs) as requested and complete monitoring visit and QOV reports on time.
• Assist with investigator and site identification.
• Assist sites in preparing Ethics Committee submissions.
• Facilitate clinical trial site contract and budget negotiations.
• Manage site queries and communications, and establish regular communication with sites and COMs.
• Assist in managing clinical trials when required.
• Provide protocol and related study training to assigned sites.
• Evaluate the quality and integrity of site practices and escalate quality issues as appropriate.
• Manage site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data-query resolution.
• Collaborate with the CRA Group and CRM on recruitment plans and contingency plans as needed.
• Perform additional tasks as assigned.

Benefits

• Medical, dental, and vision coverage.
• 401(k).
• FSA/HSA.
• Life insurance.
• Paid time off.
• Wellness benefits.
• Eligible to participate in the annual bonus plan for non-commercial roles.
• Eligible for discretionary equity awards.
• Option to voluntarily participate in the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level