Senior Clinical Research Associate

About the role

The Senior Clinical Research Associate (SCRA) is primarily a site monitor responsible for the management and oversight of clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) and provides mentorship to other CRAs.

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
• Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
• Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
• Work 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
• Collaborate 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
• Aid in other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff

Requirements

• 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
• Efficient in Microsoft Word, Excel, PowerPoint and Outlook
• Familiar with industry CTMS and data management systems

Qualifications

• BS/BA in a relevant scientific discipline
• Experience in global oncology trials preferred

Skills

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• Fosters teamwork
• Provides and solicits honest and actionable feedback
• Self-awareness
• Acts inclusively
• Demonstrates initiative
• Entrepreneurial mindset
• Continuous learning
• Communicates with clarity

Benefits

Salary Range: $105,800.00 - $140,800.00 annually

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. Packages may vary by location due to differences in the cost of labor.

The recruiter can share more about the specific salary range for a preferred location during the hiring process.

Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and 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 and to 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.