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 activities in alignment with protocols, GCP, relevant regulations, and SOPs.

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

• Collaborate with investigators and site teams to address data queries and uphold regulatory and ethical documentation.

• Assist with the Investigator Site File and supply necessary documentation for the Trial Master File.

• Coordinate CRAs as a Lead CRA on global studies, partnering with Project Management to assess study milestones and deliverables.

• Guide less experienced CRAs and site personnel, including conducting joint visits, providing feedback on monitoring reports, and delivering training specific to the study.

• Create monitoring plans, tools, and templates, and manage the shipment and receipt of study materials.

• Ensure the proper receipt, accountability, return, or destruction of investigational products at designated sites.

• Add clinical monitoring expertise to study team and investigator meetings, bid defenses, and the development of protocols and CRFs.

• Travel to investigative sites approximately 8–10 days each month.

⛳️ Requirements

• MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with a minimum of 3 years of CRA experience; OR a four-year degree in medical, biological, physical, health, pharmacy, or another related science with at least 5 years of CRA experience; OR a two-year college curriculum or equivalent education/training, ideally in nursing or life sciences, with a minimum of 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 applicable local regulatory requirements.

• Strong expertise in two to three therapeutic areas.

• Proven leadership and communication abilities, with the capability to mentor colleagues, direct site teams, solve issues, manage priorities, and contribute to enhancements in monitoring and site-management processes.

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

• Experience in full-service monitoring is preferred.

• A valid current passport and driving license.

• Proficient in both spoken and written English.

• Must be a resident of the United Kingdom.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Chance to learn and advance professionally.

• Meaningful work that enhances patient lives through clinical research.