Senior Clinical Research Associate

About the role

WEP Clinical is seeking a Senior Clinical Research Associate to join our mission-driven organization. In this role, you will be instrumental in driving impactful solutions that enhance outcomes for both clients and patients. We foster an environment that encourages innovation and collaboration, empowering team members to develop ideas that create meaningful change. This position offers the opportunity to contribute to the advancement of clinical research and the transformation of lives. You will operate at a strategic level, influencing the direction of clinical projects and ensuring that deliverables meet the highest standards of quality and integrity. The role requires a proactive mindset to navigate challenges and turn complex requirements into streamlined processes. You will be a key driver in optimizing monitoring activities to improve efficiency and effectiveness across the study portfolio. Ultimately, your work will ensure that clinical trials are conducted, recorded, and reported with the utmost professionalism.

Role Objectives

The Senior Clinical Research Associate is responsible for overseeing the complete monitoring and management of assigned studies. This includes ensuring strict compliance with Good Clinical Practice (GCP), global regulatory requirements, and all internal Standard Operating Procedures (SOPs). The role involves conducting both on-site and remote monitoring activities to guarantee protocol adherence, data integrity, and the protection of patient safety. You will serve as the primary liaison between sponsors, clinical sites, and internal departments, ensuring studies progress smoothly from initiation to closeout. A key responsibility includes developing study-specific procedures, such as Monitoring Plans, and potentially training or coordinating the activities of other CRAs. You are expected to manage the full monitoring journey for your studies, translating intricate protocols into actionable steps for sites. Your expertise will be vital in safeguarding data integrity and ensuring patient safety throughout the trial lifecycle. Success in this role requires the ability to act as a central hub for communication, aligning the objectives of sponsors, sites, and internal teams to keep studies on schedule and on target.

Key Facts

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Location: Remote (USA)

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Engagement: Full-Time

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Compensation: 120,000 USD yearly

What you'll do

• Build and maintain trust with clinical sites and sponsors to clarify expectations and resolve monitoring issues proactively.
• Design customized monitoring strategies tailored to the complexity of each protocol and specific study requirements.
• Coordinate the execution of both remote and on-site monitoring visits, ensuring data, documents, and timelines remain inspection-ready.
• Lead the implementation of new standard operating procedures for monitoring activities across the clinical team.
• Drive the creation of monitoring plans and related documentation for complex study designs.
• Ensure site staff receive thorough training and fully understand procedures to maintain consistency in expectations and execution.
• Conduct timely reviews of case report forms and source data to identify and correct discrepancies prior to submission.
• Partner with internal groups to align study timelines, manage risk, and address operational dependencies.
• Translate complex study protocols into clear, actionable steps for clinical site staff to ensure accurate execution.
• Act as the central communication hub to align the objectives of sponsors, sites, and internal teams effectively.
• Oversee the complete monitoring journey of studies to keep them on schedule and on target.
• Translate intricate protocols into actionable steps for sites to facilitate smooth execution.
• Safeguard data integrity and ensure patient safety throughout the entire trial lifecycle.
• Manage multiple studies simultaneously while maintaining high-quality documentation and exceptional attention to detail.
• Ensure monitoring activities are optimized to improve efficiency and effectiveness across the study portfolio.

Requirements

• Bring a minimum of three years of hands-on experience in clinical research monitoring roles.
• Demonstrate direct experience with complex study designs involving multiple sites and strict timelines.
• Show a strong understanding of global regulatory expectations and current Good Clinical Practice (GCP) standards for clinical trials.
• Exhibit the ability to manage multiple studies simultaneously while maintaining high-quality documentation and exceptional attention to detail.
• Possess the capability to serve as a primary liaison between sponsors, clinical sites, and internal departments.
• Adhere strictly to internal Standard Operating Procedures (SOPs) and global regulatory guidelines.
• Maintain a proven track record of ensuring protocol adherence, data integrity, and patient safety.
• Operate effectively in a remote setting while managing demanding timelines and complex study portfolios.
• Ensure all monitoring documentation remains inspection-ready at all times.
• Contribute to the development and implementation of monitoring strategies and standard operating procedures.

Nice to have

Candidates with experience in specific therapeutic areas or complex trial designs referenced in the job posting will be considered advantageous.

Practical notes

• Please What you'll do