Lead Clinical Research Specialist

2 weeks ago

Emeryville, California, United States BeiGene Full time

Overview: The Lead Clinical Research Specialist (LCRS) plays a pivotal role in overseeing and managing clinical study sites, ensuring the integrity of data and the safety of participants in alignment with ICH-GCP standards, local regulations, and relevant SOPs.

The LCRS works closely with Clinical Study Teams (CSTs) to facilitate daily clinical study operations, contribute to departmental initiatives, and mentor junior CRA team members within established guidelines and project portfolios under general oversight.

This position actively seeks opportunities to enhance processes and drive improvements to maximize the effectiveness and efficiency of the Site Management team and the broader Americas region.


Key Responsibilities:



  • Execute and coordinate clinical monitoring activities in compliance with GCPs and SOPs to evaluate the safety and efficacy of investigational products and/or medical devices.
  • Conduct site assessments to verify adherence to protocols and regulatory requirements, and prepare necessary documentation.
  • Foster collaborative relationships with investigative sites and study vendors.
  • Monitor enrollment progress to ensure study sites achieve their recruitment targets.
  • Maintain up-to-date study-specific status reports regarding site challenges, deviations, and CRF status, ensuring accuracy by the monitoring team.
  • Act as a mentor/trainer for less experienced CRAs, addressing general and study-specific monitoring concerns.
  • Provide direct assistance to the Clinical Study Manager by supporting the review of monitoring visit reports and other managerial tasks as required.
  • Conduct study-specific training sessions with project teams.
  • Develop tailored monitoring tools and documentation for the monitoring team to facilitate efficient data review.
  • Oversee Serious Adverse Event (SAE) reconciliation and collaborate with study sites and CRAs to resolve discrepancies.
  • Review outstanding data reports and coordinate with CRAs to ensure compliance with data collection per contractual obligations.
  • Collaborate with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Teams (CST) to manage site performance through dashboard evaluations and ongoing risk assessments, ensuring adherence to quality standards and addressing study delivery concerns.
  • Work with CST and clinical study sites to ensure timely achievement of study milestones (e.g., study initiation, recruitment, database analyses, closeout, etc.).
  • Support study sites and CRAs in preparation for audits/inspections and quality issues, ensuring follow-through on audit findings to resolution as it pertains to involved CRA personnel.
  • Assist with additional clinical responsibilities within the scope of the role to promote best practices and support junior clinical staff.

Supervisory Duties:



  • Provide site-level management for established protocols and project portfolios under general supervision.
  • Offer mentoring and support to CRAs on study-related topics.
  • Identify development opportunities and deliver necessary training for junior team members as required.
  • Co-monitor with CRAs and assist with site visits as needed.

Core Competencies:
  • Ethics: Treats individuals with respect; inspires trust; operates with integrity and adheres to organizational values.
  • Planning/Organizing: Prioritizes tasks effectively; utilizes time efficiently; completes administrative responsibilities accurately and punctually.
  • Communication: Listens attentively; responds to inquiries effectively; articulates clearly in various situations; writes clearly and informatively.
  • Teamwork: Balances individual and team responsibilities; welcomes feedback; contributes to a positive team atmosphere; prioritizes team success.
  • Adaptability: Adjusts to changes in the work environment; manages competing demands; modifies approaches as necessary.
  • Technical Skills: Evaluates personal strengths and areas for development; pursues training and growth opportunities; continuously enhances knowledge and skills.
  • Dependability: Follows directions; takes ownership of actions; fulfills commitments; works diligently to achieve goals.
  • Quality: Demonstrates thoroughness; seeks to enhance quality; applies feedback to improve performance.
  • Analytical: Synthesizes diverse information; conducts data research; utilizes intuition alongside data.
  • Problem Solving: Identifies and resolves issues promptly; gathers and analyzes information effectively.
  • Project Management: Communicates updates and progress; completes projects within timelines and budgets.

Technical Proficiencies:


  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
  • Familiar with industry-standard CTMS and data management systems.

Additional Qualifications:
  • Comprehensive understanding of clinical trial processes with in-depth knowledge of ICH and associated regulatory guidelines.
  • Minimum of 4-6 years of relevant Clinical Operations experience.
  • Minimum of 3-4 years of monitoring experience as a CRA in the pharmaceutical or CRO industry.
  • Exceptional communication and interpersonal skills.
  • Strong organizational abilities with a capacity to prioritize and manage multiple tasks.
  • Willingness to travel up to 40-60% of the time.

Education: Bachelor’s degree in a relevant scientific discipline, along with a minimum of 4-6 years of pertinent Clinical Operations experience and 3-4 years of monitoring experience.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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