Clinical Research Associate II – Site Leader & Mentor

BeOne Medicines; San Mateo (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

BeOne Medicines seeks a dedicated Clinical Research Associate to serve as a primary CRA and site manager. You will conduct site visits (PSSV, SIV, IMV, COV) and build strong relationships with site personnel while ensuring effective communication.

You will monitor data quality and patient safety through monitoring and site education, completing all aspects of the clinical monitoring process per ICH-GCP guidelines and SOPs, with up to 70% travel.

Qualifications

• BS/BA in a relevant scientific discipline with minimum 2+ years in Clinical Operations and at least 1+ year of monitoring experience.
• Experience in global oncology trials preferred.
• Understanding of ICH guidelines and regulatory requirements.
• Excellent communication and organizational abilities; fluent in English.

Responsibilities

• Perform and coordinate assigned aspects of the clinical monitoring process per GCPs and SOPs to assess safety and efficacy of investigational products or 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 indications and project-specific training as required.
• Maintain oversight of site performance by tracking enrollment, data entry into CRFs, protocol deviations, and site issues.
• Serve as mentor/trainer for less experienced CRAs to assist with monitoring issues.
• Communicate site performance to the Clinical Study Team.
• Perform SAE reconciliation and work with sites to resolve discrepancies.
• Collaborates with CST and sites to ensure timely delivery of study milestones.

Skills

Communication skills

Interpersonal skills

Organizational skills

Fluent English

Education

BS/BA in a relevant scientific discipline

2+ years of Clinical Operations experience

1+ year monitoring experience

Tools

CTMS

Data management systems

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

BeOne Medicines seeks a dedicated Clinical Research Associate to serve as a primary CRA and site manager. You will conduct site visits (PSSV, SIV, IMV, COV) and build strong relationships with site personnel while ensuring effective communication.

You will monitor data quality and patient safety through monitoring and site education, completing all aspects of the clinical monitoring process per ICH-GCP guidelines and SOPs, with up to 70% travel.