Clinical Research Associate II

BeOne Medicines USA; United States; On-site; USD 92,000 - 122,000; Full time

Job summary

BeOne Medicines USA is seeking a Clinical Research Associate (CRA) to serve as a primary CRA, conduct site visits (PSSV, SIV, IMV, COV) and manage site relationships to ensure data quality and patient safety.

You will monitor trials per ICH-GCP, provide site training, track enrollment and data entry, mentor junior CRAs, and support study milestones with cross-functional teams. Travel up to 70% is required.

Qualifications

• BS/BA in a relevant scientific discipline with 2+ years of clinical operations experience.
• Minimum 1+ year of monitoring experience; oncology trials preferred.
• Fluent in English; excellent communication and organizational skills.

Responsibilities

• Perform and coordinate clinical monitoring per GCP and SOPs.
• Conduct site visits for protocol and regulatory compliance.
• Develop collaborative relationships with investigative sites and vendors.
• Provide protocol training to study sites.
• Track enrollment, data entry, deviations, and site issues.
• Mentor junior CRAs and share monitoring knowledge.

Skills

Fluent English

Education

BS/BA in a relevant scientific discipline

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 CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible for building and maintaining relationships with key site personnel and ensures an effective line of communication. The CRA will also monitor data quality and patient safety through monitoring and site education. CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.

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
• Provide protocol and related study training to assigned clinical study sites
• Attend disease indication and/or project specific training, as required
• Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues
• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
• Communicate site performance to the Clinical Study Team (CST)
• Perform study-specific training with project team
• Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies
• Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
• Attend regional investigator meeting and site booster visits, as required
• Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed
• Assist with other assigned clinical responsibilities within scope of role, as required

Supervisory Responsibilities

• Provides site level management for established protocols and portfolio under general supervision
• Provides mentoring/support to CRAs for CRA related topics
• 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
• undefined

Other Qualifications

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English (writing and speaking)

Travel

Travel: Up to 70% travel

Education/ Education Required

• BS/BA in a relevant scientific discipline and minimum of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring experience.
• Experience in global oncology trials preferred.

Global Competencies

• 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: $92,000.00 - $122,000.00 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 Wel