Clinical Research Associate II
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Job Description
Clinical Research Associate monitoring clinical sites and patient safety for BeOne, a company developing cancer medicines. Managing compliance, data quality, training, and study milestones.
Responsibilities:
- Assume the role of a primary CRA and function as the site manager
- Conduct site visits, including PSSV, SIV, IMV, and COV
- Build and maintain relationships with key site personnel
- Monitor data quality and patient safety through monitoring and site education
- Complete all aspects of clinical monitoring in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs
- 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 study training to assigned clinical study sites
- Maintain oversight of site performance by tracking enrollment, CRF data entry, protocol deviation trends, and site issues
- Mentor and train less experienced CRAs
- Communicate site performance to the Clinical Study Team
- Perform study-specific training with the project team
- Reconcile Serious Adverse Events and resolve discrepancies with study sites
- Collaborate with the CST and clinical study sites to deliver study milestones
- Attend regional investigator meetings and site booster visits as required
- Support audit and inspection preparation and follow quality findings to resolution
- Provide site-level management and co-monitoring support
Requirements:
- BS/BA in a relevant scientific discipline
- Minimum of 2+ years of relevant Clinical Operations experience
- Minimum of 1+ years of monitoring experience
- Experience in global oncology trials preferred
- Efficient in Microsoft Word, Excel, PowerPoint and Outlook
- Familiar with industry CTMS and data management systems
- Thorough knowledge of ICH and associated regulatory guidelines
- Fluent in English (writing and speaking)
- Up to 70% travel
Benefits:
- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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