Senior Clinical Research Associate

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

📋 Description

• Propel AbbVie's clinical research pipeline forward and aid in the development of groundbreaking medicines.

• Act as the primary liaison between the sponsor and investigative sites.

• Deliver contextual information regarding clinical trials and connect stakeholders with investigative sites.

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

• Mentor and guide junior personnel and Clinical Research Associates (CRAs) in site management activities.

• Conduct evaluations of sites, provide training, and carry out routine monitoring both on-site and remotely, as well as oversee site closure monitoring.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards.

• Create and tailor site engagement strategies while tracking their effectiveness and impact.

• Collect local and site-specific insights to enhance engagement and study performance.

• Develop strategies for recruitment and retention based on the patient disease journey.

• Participate in or take the lead on global and local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team to identify study performance or patient safety issues.

• Address site risk signals and implement preventive and corrective action plans.

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

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

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

• Manage investigator payments in accordance with executed contractual obligations, where applicable.

⛳️ Requirements

• A minimum of 3 years of experience in a clinically related role.

• Ideally, 2 years of independent experience in clinical research monitoring involving investigational drug or device trials.

• Familiarity with risk-based monitoring and both on-site and off-site monitoring practices.

• Knowledge of therapeutic area indications and the ability to apply scientific concepts to the conduct of clinical trials.

• Understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Advanced communication skills and the ability to collaborate across functions.

• Strong planning and organizational capabilities, with the ability to manage competing projects and deadlines.

• Proficiency in leveraging technology, tools, and resources to provide site support focused on customer needs.

• Exceptional written, verbal, active listening, and presentation abilities.

• Capacity to build site relationships and trusted partnerships through engagement, motivation, and training.

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

• Integrity aligned with AbbVie’s code of business conduct and leadership principles.

• A self-motivated approach with an emphasis on achieving timely, quality outcomes in a dynamic environment.

🏝️ Benefits

• Option for remote work.

• Equal opportunity employer.

• Commitment to operating with integrity, fostering innovation, transforming lives, and serving the community.