Senior Clinical Research Associate - Oncology

BeiGene

2d•$105,800 - $140,800

About The Position

The Senior Clinical Research Associate (SCRA) is primarily a site monitor responsible for managing and overseeing assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA supports day-to-day clinical study activities and departmental tasks, mentors other CRA team members, and works under general supervision within established protocols and portfolio. The role also seeks opportunities to lead improvements that optimize effectiveness and efficiency within the Site Management group and the greater Americas region. The SCRA collaborates with Clinical Study Teams, study sites, vendors, CRAs, Clinical Study Managers, and Clinical Trial Oversight Managers to support study delivery, site quality, risk assessment, and timely achievement of study milestones. The position requires a relevant scientific bachelor’s degree, substantial Clinical Operations and CRA monitoring experience, and travel of up to 40–60% of the time.

Requirements

Bachelor of Science or Bachelor of Arts degree in a relevant scientific discipline.
Minimum of 4–6 years of relevant Clinical Operations experience.
Minimum of 3–4 years of CRA monitoring experience in the pharmaceutical or CRO industry.
Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines.
Excellent communication and interpersonal skills.
Excellent organizational skills and ability to prioritize and multitask.
Efficient in Microsoft Word, Excel, PowerPoint, and Outlook.
Travel up to 40–60% of the time.

Nice To Haves

Experience in global oncology trials.
Familiarity with industry CTMS and data management systems.

Responsibilities

Perform and coordinate assigned aspects of clinical monitoring 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.
Track enrollment status reports to help ensure sites meet enrollment goals.
Track study-specific status reports so information regarding site issues, deviations, and CRF status remains current for the monitoring team.
Mentor and train less experienced CRAs on general and study-specific monitoring issues.
Support the Clinical Study Manager by assisting with monitoring visit report reviews and other managerial tasks as needed.
Conduct study-specific training with the project team.
Develop study-specific monitoring tools and forms to support efficient review of study data.
Perform Serious Adverse Event (SAE) reconciliation and work with sites and CRAs to resolve discrepancies.
Review outstanding data reports and work with CRAs to ensure data collection meets contractual guidelines.
Work with CTOMs and the CST to manage site trends through dashboard review and ongoing risk assessment, maintain quality standards, and address site study-delivery concerns.
Collaborate with the CST and clinical study sites to support timely delivery of study milestones, including startup, recruitment, database analyses, and closeout.
Support study sites and CRAs with audit and inspection preparation and responses, quality issues, and follow-through on findings involving CRA staff.
Assist with other assigned clinical responsibilities within role scope to support best practices and junior clinical staff.
Provide site-level management for established protocols and portfolio under general supervision.
Identify development opportunities and provide necessary training to junior team members.
Co-monitor with CRAs and support site visits as needed.