Clinical Research Associate

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

📋 Description

• Propel AbbVie’s clinical development pipeline by aiming for excellence in clinical research and utilizing advanced capabilities.

• Act as the primary liaison for investigative sites.

• Provide contextual insights on clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Execute site evaluations, training, routine monitoring, and site closure activities.

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

• Tailor site engagement strategies and employ CRM tools to monitor progress and assess impact.

• Integrate study protocols and scientific principles into the daily execution of trials.

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

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and protocol adherence.

• Mentor and train junior CRAs and support their professional development.

• Engage in global or local task forces and initiatives.

• Perform continuous risk assessments with the Central Monitoring team to identify study performance or patient safety concerns.

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

• Identify, assess, and recommend potential investigators and clinical trial sites.

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

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

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

⛳️ Requirements

• A relevant tertiary qualification in health-related fields such as Medical, Scientific, or Nursing is preferred.

• A minimum of 1 year of clinically-related experience.

• At least 6 months of experience in clinical research monitoring involving investigational drug or device trials.

• Familiarity with risk-based monitoring, including both onsite and offsite monitoring.

• Knowledge of relevant therapeutic area indications is preferred.

• Ability to comprehend and apply scientific concepts to the execution of clinical trials.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities; capable of managing competing projects and deadlines.

• Advanced capability to utilize technology, tools, and resources effectively.

• Exceptional interpersonal, written, verbal, active listening, and presentation skills.

• Ability to build relationships and establish trusted partnerships with sites through engagement, motivation, and training.

• Capability to apply critical thinking and sound judgment to clinical site challenges.

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

• Self-driven and focused on achieving timely, high-quality outcomes in a dynamic environment.

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

• AbbVie is dedicated to operating with integrity, fostering innovation, transforming lives, and serving the community.