Senior Clinical Research Associate (SCRA)
About us
BeOneis 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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing,and Cambridge, U.S. Tolearn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOnecontinues 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.
Job Description:
General Description:
The primary responsibilities of a SCRA include managing and overseeing clinical trials, delivering high-quality data within established timelines and following monitoring procedures compliant with GCP, ICH guidelines, local regulations, and standard operating procedures (SOPs). CRAs collaborate closely with various stakeholders involved in clinical trials to support their setup and execution while safeguarding the rights and safety of trial participants.
Essential Functions of the Job:
- Monitor clinical trial sites to ensure compliance with the study protocol, ICH-GCP, and regulatory requirements.
- Perform Pre-Study Site Selection, initiation, routine monitoring, co-monitoring and close-out visits.
- Verify the accuracy, completeness, and integrity of case report forms (CRFs) and source documents.
- Identify and resolve site issues and provide appropriate training to site staff.
- Evaluates the quality and integrity of site practices, escalating quality issues as appropriate.
- Ensure proper documentation of study activities and timely data collection.
- Ensure study milestones are met as planned for assigned sites
- Maintain regular communication with investigators, site staff, and internal project teams.
- Assist with regulatory submissions, ethics submissions, and site contract negotiations as needed.
- Prepare monitoring visit reports and follow-up letters in a timely manner and as per applicable SOPs.
- Support audit readiness and participate in sponsor or regulatory inspections when necessary.
- Manages site performance by tracking recruitment and enrolment, case report form (CRF) completion, and data query resolution.
- Collaborates with CRA Group / CRM to ensure recruitment plans are executed and contingency plans are in place, as needed.
- Collaborates with study team members for study execution support as appropriate.
- Ability to manage multiple tasks, prioritize effectively, and handle time-sensitive deadlines throughout the study lifecycle.
- Attends onboarding, disease indication and project specific training and general CRA training as required.
- Conducts Assessment Visits (AV), as requested
- Assists in managing clinical trials, if required
- Performs additional task as assigned.
Supervisory Responsibilities: Not Applicable
Qualification Required:
Education Required:
- Bachelor’s degree or higher in life sciences, pharmacy, nursing or medicine.
- >3.5 years of monitoring experience in clinical trials (CRA or Sponsor)
- Strong understanding of ICH-GCP, clinical trial processes, and regulatory guidelines.
Computer Skills: Must be efficient in Microsoft Word, Excel, PowerPoint, and Outlook
Other Qualifications: Fluent in written and verbal English
Travel: Within Australia & New Zealand as needed. Must hold a valid driver’s license and well-maintained vehicle suitable for business travel
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.