BeiGene · 4 months ago
Senior Clinical Research Associate
United States
Full-time
Remote
Mid, Senior Level
$106K/yr - $141K/yr
4+ years expBeOne Medicines USA is a rapidly growing company focused on fighting cancer, seeking a Senior Clinical Research Associate (SCRA) to oversee clinical study sites. The SCRA will ensure data quality and patient safety, collaborate with Clinical Study Teams, and mentor junior CRAs while driving improvements in site management.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
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
Develop collaborative relationships with investigative sites, and study vendors
Track enrollment status reports to ensure study sites stay on track to meet enrollment goals
Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team
Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks as needed
Perform study-specific training with project team
Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
Perform Serious Adverse Event (SAE) reconciliation and work with study sites and CRAs to resolve discrepancies
Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines
Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to manage site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites within established protocols and portfolio under general supervision
Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
Provide support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff
Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff
Provides site level management for established protocols and portfolio under general supervision
Provides mentoring/support to CRAs for study related topics
Identification of development opportunities and provides necessary training to for junior team members as needed
Co-monitoring with CRAs and support site visits, as needed
Qualification
Required
Understand clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
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
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience
Efficient in Microsoft Word, Excel, PowerPoint and Outlook
Familiar with industry CTMS and data management systems
Preferred
Experience in global oncology trials
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeiGene
BeiGene is a global oncology company.
0-1 employees
H1B Sponsorship
BeiGene has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (32)
2023 (39)
2022 (40)
2021 (28)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$6.79BKey Investors
Hillhouse InvestmentAmgen
2020-07-12Post Ipo Equity· $2.08B
2019-10-31Post Ipo Equity· $2.7B
2018-08-02Post Ipo Secondary· $903M
Leadership Team
Dirk Weber
Executive Director Medical Affairs (Europe)
Lai Wang
Global Head of Research and Development
Recent News
2026-01-07
Company data provided by crunchbase