Senior Clinical Research Associate

2 weeks ago

San Mateo, California, United States BeiGene Full time
Job Summary

The Senior Clinical Research Associate will be responsible for the management and oversight of clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines and local regulations. This role will collaborate with the Clinical Study Teams to support day-to-day clinical study activities and provide mentoring to junior team members.

Key Responsibilities
  • Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs.
  • 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.
Requirements
  • 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.
  • Travel: up to 40-60% time.
Education

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. Experience in global oncology trials preferred.

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