Senior Clinical Research Associate - Oncology

BeOne Medicines USA, Inc.; United States; Remote; USD 106,000 - 141,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. is seeking an experienced Senior Clinical Research Associate (SCRA) to oversee assigned clinical study sites, ensure data integrity and patient safety in accordance with ICH-GCP guidelines. The SCRA will support day-to-day trial activities, mentor junior CRAs, and collaborate with CSTs and CTOMs across the Americas region to meet enrollment milestones and quality standards.

Travel up to 40-60% is required to monitor sites and coordinate with study teams.

Qualifications

• BS/BA in a relevant scientific discipline with 4-6 years clinical operations experience.
• 4-6 years of clinical operations experience and 3-4 years CRA monitoring.
• Experience in global oncology trials preferred.

Responsibilities

• Perform site monitoring per GCPs to ensure data quality and patient safety.
• Conduct site visits for protocol and regulatory compliance.
• Mentor and train junior CRAs.
• Collaborate with CSTs and CTOMs to manage site trends.
• Assist with audits/inspections preparation and responses.

Skills

Clinical monitoring

ICH-GCP

Regulatory knowledge

Communication

Leadership

Education

BS/BA in relevant scientific discipline

Tools

CTMS

Microsoft Office

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Senior Clinical Research Associate (SCRA) is primarily a site monitor and is responsible for the management and oversight of their assigned 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) by supporting day to day clinical study activities, departmental tasks, and provides mentoring to other CRA team members within established protocols and portfolio under general supervision. Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management group as well as within the greater Americas region.

Essential Functions of the job

• 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.

Supervisory Responsibilities

• 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

Computer Skills

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

Other Qualifications

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• 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
• Experience in global oncology trials preferred.
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Travel: up to 40 -60% time

Education/ Experience Required

BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience. Experience in global oncology trials preferred.

Global Competencies

Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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: $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.

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

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 [e-mail].

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.

• Patients First
• Driving Excellence
• Bold Ingenuity
• Collaborative Spirit