[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a rapidly growing company focused on fighting cancer, seeking experienced professionals for their team. The Senior Clinical Research Associate (SCRA) is responsible for the management and oversight of clinical study sites, ensuring data quality and patient safety while collaborating with clinical study teams to drive improvements and support study activities.

Responsibilities

• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
• Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
• Develop collaborative relationships with investigative sites, and study vendors
• Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
• Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team
• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
• Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
• Perform study-specific training with project team
• Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
• Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies
• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
• Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites within established protocols and portfolio under general supervision
• Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Provide support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff
• Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff
• Provides site level management for established protocols and portfolio under general supervision
• Provides mentoring/support to CRAs for study related topics
• Identification of development opportunities and provides necessary training to for junior team members as needed
• Co-monitoring with CRAs and support site visits, as needed

Skills

• BS/BA in a relevant scientific discipline
• Minimum of 4-6 years of relevant Clinical Operations experience
• Minimum of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Understand clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• Efficient in Microsoft Word, Excel, PowerPoint and Outlook
• Familiar with industry CTMS and data management systems
• Experience in global oncology trials

Benefits

• Non-Commercial roles are eligible to participate in the annual bonus plan
• Commercial roles are eligible to participate in an incentive compensation plan
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
• Voluntarily participate in the Employee Stock Purchase Plan
• The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Company Overview

Company H1B Sponsorship