Clinical Research Associate II

BeiGene

1d • $92,000 - $122,000

About The Position

The Clinical Research Associate II serves as a primary CRA and site manager, conducting site visits such as PSSV, SIV, IMV, and COV. The role builds and maintains relationships with key site personnel, supports effective communication, and monitors data quality and patient safety through monitoring and site education. The CRA completes clinical monitoring activities in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.

The position provides site-level management for established protocols and portfolios under general supervision, and mentors and supports other CRAs. It works with clinical study teams, investigative sites, and vendors to support study milestones, site performance, safety reporting, and inspection readiness. Travel is up to 70%.

Requirements

• Bachelor of Science or Bachelor of Arts degree in a relevant scientific discipline.
• At least 2 years of relevant Clinical Operations experience.
• At least 1 year of monitoring experience.
• Thorough understanding of clinical trial processes, ICH, and associated regulatory guidelines.
• Excellent communication and interpersonal skills.
• Excellent organizational skills and the ability to prioritize and multitask.
• Fluent in written and spoken English.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Familiarity with industry CTMS and data management systems.

Nice To Haves

• Experience in global oncology trials.

Responsibilities

• Perform and coordinate clinical monitoring activities in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices.
• Conduct site visits to assess protocol and regulatory compliance and prepare required documentation.
• Develop collaborative relationships with investigative sites and study vendors.
• Provide protocol and study-related training to assigned sites and study-specific training to project team members.
• Attend disease indication or project-specific training as required.
• Track enrollment, Case Report Form (CRF) data entry, protocol deviation trends, and overall site issues to maintain oversight of site performance.
• Mentor and train less experienced CRAs on general and study-specific monitoring issues.
• Communicate site performance to the Clinical Study Team (CST).
• Perform Serious Adverse Event (SAE) reconciliation and work with sites to resolve discrepancies.
• Collaborate with the CST and clinical study sites to support timely study milestones, including startup, recruitment, database analyses, and closeout.
• Attend regional investigator meetings and site booster visits as required.
• Support audit and inspection preparation at clinical study sites and follow quality issues or findings through resolution as needed.
• Provide site-level management for established protocols and portfolios under general supervision.
• Provide CRA-related mentoring and support, co-monitor with CRAs, and support site visits as needed.
• Assist with other assigned clinical responsibilities within the scope of the role.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• FSA/HSA
• Life insurance
• Paid time off
• Wellness benefits
• Eligibility for the annual bonus plan for non-commercial roles or an incentive compensation plan for commercial roles
• Eligibility for discretionary equity awards
• Voluntary participation in the Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level