Senior Clinical Research Associate

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

📋 Description

• Propel AbbVie's clinical research pipeline forward while supporting innovative medicinal solutions.

• Act as the main sponsor liaison for investigative sites.

• Collaborate with study teams, internal R&D stakeholders, investigators, and site personnel.

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

• Guide and assist junior CRAs in site management tasks and their professional growth.

• Perform site evaluations, training, routine monitoring (both on-site and off-site), and site closure oversight.

• Ensure adherence to protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality benchmarks.

• Create and implement tailored site engagement strategies.

• Collect local and site insights while tracking engagement progress and its impact.

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

• Enhance knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys.

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

• Conduct ongoing risk assessments with the Central Monitoring team.

• Identify and address site risk signals, implementing preventive and corrective action plans.

• Identify, evaluate, and recommend investigators and clinical trial sites.

• Guarantee the quality and timely submission of site data and safety event reporting.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contract obligations, when applicable.

⛳️ Requirements

• Preferred tertiary qualification in health-related fields (e.g., Medical, Scientific, Pharmacy, Nursing).

• At least 3 years of clinically related experience.

• A minimum of 2 years in independent clinical research monitoring of investigational drug or device trials is preferable.

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

• Understanding of therapeutic area indications and scientific principles related to clinical trials.

• Knowledge of local regulatory and legal standards, ICH/GCP Guidelines, and relevant policies.

• Advanced communication and cross-functional collaboration abilities.

• Exceptional planning and organizational skills.

• Capability to work efficiently in a fast-paced environment with multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources.

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

• Ability to independently resolve clinical site issues using functional expertise and critical thinking.

• Capacity to act with integrity in alignment with AbbVie's business conduct code and leadership values.

• Self-driven and focused on achieving timely, quality outcomes.

🏝️ Benefits

• Opportunity for remote work.

• Commitment to equal opportunity employment.

• Inclusion of veterans and individuals with disabilities.