Senior Clinical Research Associate

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

📋 Description

• Enhance AbbVie's clinical research initiatives by aiming for excellence in clinical research.

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

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

• Supply relevant clinical trial information and link stakeholders with investigative sites.

• Inspire and unify the monitoring community through effective leadership and mentorship.

• Educate and motivate site staff and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Assist, guide, and mentor junior staff in Site Management tasks.

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

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

• Tailor site-engagement strategies and monitor progress and impact using site-engagement tools.

• Implement scientific principles and clinical trial requirements in daily trial execution.

• Create and ensure effective patient recruitment and retention strategies and plans.

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train less experienced CRAs and assist with local onboarding.

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

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

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

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

• Ensure data quality and timely submissions, including safety event reporting and follow-up.

• Maintain audit and regulatory inspection readiness at assigned clinical sites.

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

⛳️ Requirements

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

• At least 3 years of experience in clinically related roles.

• Ideally 2 years of independent clinical research monitoring for investigational drug or device trials.

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

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

• Extensive knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Advanced communication and cross-functional collaboration abilities.

• Excellent planning and organizational skills; capable of performing effectively in a fast-paced environment with competing projects and deadlines.

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

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

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

• Integrity consistent with AbbVie's code of business conduct and leadership values.

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

• Proficient in English and the local language.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

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