Clinical Research Associate

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

📋 Description

• Act as the main point of contact for investigative sites as the primary sponsor.

• Deliver contextual insights on clinical trials and link stakeholders to investigative sites.

• Align, train, and inspire site staff and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Provide support, guidance, and mentorship to junior team members involved in site management activities.

• Perform site evaluations, training sessions, routine on-site and off-site monitoring, and site closure monitoring.

• Ensure adherence to protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards.

• Personalize site engagement strategies and monitor their effectiveness and impact.

• Collect insights from local and site perspectives.

• Relate study protocols and scientific principles to everyday trial execution.

• Develop and implement effective patient recruitment and retention strategies and plans.

• Enhance knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to aid recruitment and protocol compliance.

• Engage in or lead global and local task forces and initiatives.

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

• Recognize and address site risk signals, implementing preventive and corrective action plans as necessary.

• Identify, assess, and recommend investigators and sites for upcoming clinical studies.

• Ensure the quality and timely submission of site data, including safety event reporting and follow-up.

• Maintain readiness for audits and regulatory inspections at designated sites.

• Oversee investigator payments in accordance with executed contract obligations, where applicable.

⛳️ Requirements

• Preferred tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing), or equivalent experience.

• Experience in independent clinical research monitoring of investigational drug or device trials across any therapeutic area.

• Familiarity with a risk-based monitoring approach, including both on-site and off-site monitoring.

• Understanding of relevant therapeutic area indications and the ability to apply scientific concepts to clinical trials.

• Knowledge of current and emerging local regulatory and legal requirements, as well as ICH/GCP Guidelines and applicable policies.

• Exceptional communication skills coupled with strong cross-functional collaboration abilities.

• Excellent planning and organizational skills; capability to manage competing projects and deadlines effectively.

• Ability to utilize technology, tools, and resources for customer-focused site support.

• Outstanding written, verbal, active listening, and presentation skills.

• Skill in establishing and leveraging site relationships and trusted partnerships through engagement, motivation, and training.

• Capacity to independently apply functional expertise, critical thinking, and sound judgment to resolve clinical site issues.

• Commitment to integrity in line with AbbVie’s code of business conduct and leadership values.

• Self-motivated approach, focused on achieving timely and high-quality outcomes in a fast-paced environment.

🏝️ Benefits

• Excellent opportunities for professional development.

• Comprehensive rewards and benefits package.

• Ample parking facilities for convenient access.

• Step-free entry, accessible restrooms, and elevators available.

• Provision of assistive technologies and adaptable workstations.

• Designated quiet zone for focused work.

• Equal opportunity employer dedicated to accessibility and employee well-being.