Senior Clinical Research Associate – CNS/Oncology

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee site qualification, initiation, interim monitoring, management, and close-out processes.

• Safeguard patient safety and data integrity by evaluating informed consent, safety information, source documentation, CRFs, and adherence to protocols.

• Collaborate with investigators and site teams to address data queries while ensuring compliance with regulatory, ethical, Trial Master File, and Investigator Site File documentation.

• Lead CRAs on global studies, coordinating their efforts and assessing study milestones and deliverables alongside Project Management.

• Provide mentorship to less experienced CRAs and site personnel through joint visits, feedback on monitoring reports, and targeted study training.

• Create monitoring plans, tools, and templates.

• Organize the shipment and receipt of study materials.

• Ensure the receipt, accountability, return, or destruction of investigational products.

• Offer clinical monitoring expertise during study team and investigator meetings, bid defenses, protocol discussions, and CRF reviews.

• Manage sites throughout the entire study lifecycle, from qualification and initiation to ongoing monitoring and closure.

⛳️ Requirements

• MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with a minimum of 3 years of CRA experience; or a bachelor's degree in medical, biological, physical, health, pharmacy, or a related science with at least 5 years of CRA experience; or a two-year college education or equivalent training, ideally in nursing or life sciences, with at least 7 years of CRA experience.

• Comprehensive understanding of clinical research principles and processes, GCP, SOPs, FDA and/or EU regulations and directives, ICH Guidelines, and relevant local regulatory standards.

• Strong expertise in two to three therapeutic areas.

• Proven leadership and communication abilities, with a talent for mentoring colleagues, guiding site teams, resolving issues, prioritizing tasks, and driving process enhancements.

• Proficient in Microsoft Office, IxRS, and EDC systems.

• Experience in full-service monitoring is preferred.

• Must possess a valid current passport and driving license.

• Proficient in both spoken and written English.

• Residency in the United Kingdom is required.

• Willingness to travel approximately 8–10 days per month to investigative sites.

🏝️ Benefits

• Collaborative and inclusive workplace culture.

• Opportunities for growth and career development.

• Chance to learn, evolve, and influence the future of clinical research.