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PREFERRED EXPERIENCE: Pharmaceutical/Biotech Industry, Hematology, Oncology
Company Overview:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients
General Description:
The CRA I is responsible to complete the requirements of the BeiGene CRA Training Program (12-14 weeks) prior to assignment as a primary CRA.
The CRA training program consists of instructor led training sessions, independent exercises, and in-field observation visits.
After successful completion of the training program, 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 to build and maintain relationships with key site personnel and ensure 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:
- 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 per monitoring plan and applicable SOPs
- 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
- Communicate site performance to the Clinical Study Team (CST)
- May serve as mentor/trainer for less experienced CRAs to assist with general and study -specific monitoring issues
- Perform study-specific training with project team
- Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CST 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
Minimum Requirements - Education and Experience:
BS/BA in a relevant scientific discipline. Experience working in oncology global trials and 5+ years of relevant Clinical Operations experience or 1+ years in a clinical research associate position is preferred.
Other Qualifications:
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi -task
- Fluent in English (writing and speaking)
Supervisory Responsibilities:
- Provides site level management for assigned study sites
- Co-monitoring with CRAs and support site visits, as needed
- May serve as a mentor CRA for CRAs in training
Travel: Up to 70% Travel
Computer Skills:
- Proficient in Microsoft Word, Excel, PowerPoint and Outlook Familiar with industry software such as CTMS, investigational product and data management systems
BeiGene 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
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.