Clinical Research Associate I

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

📋 Description

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

• Offer contextual details regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

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

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

• Tailor site engagement strategies and collect insights from local sites.

• Report and track the progress of site engagement and evaluate the impact of strategies.

• Connect study protocols, scientific principles, and clinical trial requirements to the daily execution of trials.

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

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

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify, assess, and recommend investigators and sites.

• Ensure the quality and timely submission of study data and safety event reports.

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

• Manage investigator payments in accordance with contractual obligations.

⛳️ Requirements

• Bachelor's degree or equivalent; a health-related field is preferred (e.g., Medical, Scientific, Nursing, Pharmacy).

• Preferred clinically related experience in clinical research coordination or data management.

• Familiarity with relevant therapeutic area indications is preferred.

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

• Ability to collaborate effectively across functions.

• Strong planning and organizational abilities; adept at working efficiently in a dynamic environment with multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources.

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

• Ability to establish and cultivate site relationships and trusted partnerships through engagement, motivation, and training.

• Utilizes functional expertise, critical thinking, and sound judgment to tackle clinical site issues.

• Acts with integrity in alignment with AbbVie’s code of business conduct and leadership values.

• Self-driven and focused on delivering quality outcomes promptly in a fast-paced environment.

🏝️ Benefits

• Full-time employment.

• Equal opportunity employment.

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