Senior Clinical Research Associate – FSP

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

📋 Description

• Oversee the preparation, initiation, ongoing monitoring, and closure of designated clinical trial sites.

• Act as the main point of contact for investigative sites, assisting in study execution and patient recruitment objectives.

• Educate, support, and guide investigators and site staff on study requirements, protocol implementation, and Risk Based Quality Management principles.

• Conduct both onsite and remote monitoring visits, including source data review, source data verification, and case report form assessment.

• Identify, manage, and escalate site and study challenges to ensure timely resolutions.

• Carry out site quality risk evaluations and modify monitoring activities throughout the study lifecycle.

• Guarantee prompt and precise reporting of serious adverse events, resolution of queries, and quality data collection.

• Keep study information updated in CTMS and other clinical systems.

• Assist in the collection, review, uploading, and maintenance of essential documents in the eTMF and investigator site files.

• Collaborate with study teams, quality colleagues, and stakeholders regarding audits, inspections, and study delivery.

• Manage study supplies, oversee study drug accountability activities, and maintain relevant documentation.

• Offer insights on site performance, investigator engagement, and local research environments.

⛳️ Requirements

• Bachelor’s degree in a life science or related field, or equivalent experience aligned with local market standards.

• Extensive clinical research experience with proven skills in site monitoring and clinical trial execution.

• Strong understanding of ICH GCP and a working knowledge of relevant local regulatory standards.

• Good grasp of clinical study management, study drug handling, data management, and clinical trial processes.

• Proficient in using CTMS, eTMF, and other clinical research technologies and systems.

• Exceptional written and verbal communication, organizational, and problem-solving abilities.

• Proficient in written and spoken English.

• Willingness to travel nationally and internationally as needed.

• Valid driving license in accordance with local country regulations, where applicable.

• Preferred: Experience in supporting global clinical studies within a pharmaceutical or biotechnology setting.

• Preferred: Familiarity with risk-based monitoring strategies, including remote monitoring techniques.

• Preferred: Experience as a CRA/Senior CRA in Oncology clinical trials.

• Preferred: Background in facilitating regulatory inspections and audit readiness activities.

• Preferred: Strong cultural awareness and experience in collaborating with global teams.

• Preferred: Proven ability to identify efficiencies and contribute to high-quality clinical trial delivery.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Vacation/Holiday/Sick Time.

• Flexible benefit portal.

• Car or car allowance (only applicable roles).