Clinical research associate i (cra i) - oncology

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 performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country. The CRA is responsible for delivering data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.

Essential Functions of the Job:

• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
• Conducts co-monitoring visits, if required
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Attends onboarding, disease indication and project specific training and general CRA training as required
• Documents monitoring activities appropriately following ICH-GCP and BeOne standards
• Conducts Quality Oversight Visits (QOV), as requested
• Completes monitoring visit/ QOV reports timely
• Assists with investigator/site identification
• Assists site to prepare Ethics Committee submissions
• Facilitates clinical trial site contract and budget negotiation
• Manages site queries and communications
• Assists in managing clinical trials, if required
• Establishes regular lines of communication with sites and COMs
• Provides protocol and related study training to assigned sites
• Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
• Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
• Performs additional task as assigned

Computer Skills:

Efficient in Microsoft Word, Excel, PowerPoint, OneNote, and Outlook. Familiar with industry EMR, CTMS, Site File Management, and data management systems.

Other Qualifications:

At least 2 years of Clinical Research Coordinator experience in Oncology. 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).

Additional Experience:

Early Phase Preferred. Hematology and Solid Tumor Experience Preferred.

Travel:

Up to 70% travel- multi regional.

Education Required:

Bachelor’s degree or above in life sciences, pharmacy, nursing or medical. Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines.

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:

$80,000.00 - $105,000.00 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.

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 accommodationsus@beonemed.com.