Clinical Research Associate I – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Carry out pre-study, initiation, routine monitoring, closeout, and co-monitoring visits for Oncology and Hematology clinical trials.

• Ensure that study milestones, such as startup, recruitment, database analyses, and closeout, are achieved.

• Participate in onboarding, disease indication, project-specific, and CRA training sessions.

• Record monitoring activities in accordance with ICH-GCP and BeOne standards.

• Perform Quality Oversight Visits as requested.

• Timely completion of monitoring visit and QOV reports.

• Assist in identifying investigators/sites and submitting to Ethics Committees.

• Facilitate negotiations regarding clinical trial site contracts and budgets.

• Manage site queries and maintain communications.

• Provide assistance in managing clinical trials as necessary.

• Establish consistent communication with sites and Clinical Operations Managers.

• Deliver protocol and study training to designated sites.

• Assess site practice quality and integrity, escalating quality issues when necessary.

• Monitor regulatory submissions, recruitment, CRF completion, and the resolution of data queries.

• Work collaboratively with the CRA Group and CRM on recruitment and contingency strategies.

• Ensure the delivery of quality data within set timelines while adhering to monitoring procedures, GCP, ICH, local regulations, and SOPs.

⛳️ Requirements

• Minimum of 2 years of experience as a Clinical Research Coordinator in Oncology.

• Comprehensive understanding of clinical trial processes, ICH, and relevant regulatory guidelines.

• Strong communication and interpersonal abilities.

• Exceptional organizational skills with the capacity to prioritize and handle multiple tasks.

• Proficiency in English, both written and spoken.

• Skilled in Microsoft Word, Excel, PowerPoint, OneNote, and Outlook.

• Familiarity with industry EMR, CTMS, Site File Management, and data management systems.

• Bachelor’s degree or higher in life sciences, pharmacy, nursing, or medicine.

• Willingness to travel up to 70% across multiple regions.

• Experience in Early Phase preferred.

• Background in Hematology and Solid Tumor preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Participation in a Voluntary Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account (FSA/HSA).

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.