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
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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:
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
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: $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 Wellness.
