Clinical Research Associate

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

📋 Description

• Oversee activities at clinical investigative sites for AbbVie clinical studies to guarantee effective protocol implementation.

• Ensure compliance with federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards.

• Perform site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies.

• Supervise site personnel activities and inspire them to achieve study objectives.

• Actively manage sites and execute action plans to ensure adherence to compliance.

• Maintain regulatory inspection readiness at designated clinical sites.

• Safeguard data quality and timely submissions, including safety-event reporting and follow-ups.

• Protect study-subject safety through compliance with monitoring plans, SOPs, guidelines, and regulations.

• Educate site personnel on protocols and regulatory requirements alongside project team members.

• Oversee investigator payments in accordance with executed contract obligations.

• Negotiate agreements with investigators and hospitals in collaboration with stakeholders.

• Complete expense reports following local and relevant guidelines.

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

⛳️ Requirements

• Relevant tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) is preferred.

• At least 1 year of clinically-related experience, with a minimum of 6 months in clinical research monitoring preferred.

• Experience in on-site monitoring of investigational drug or device trials is required.

• Up-to-date comprehensive knowledge of therapeutic indications related to clinical trials.

• Current thorough knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations.

• Excellent planning and organizational skills.

• Ability to work effectively and efficiently in a fast-paced environment with competing projects and deadlines.

• Capability to understand and adhere to work processes within the assigned function.

• Strong analytical and conceptual skills.

• Excellent interpersonal skills with the ability to communicate clearly.

• Ability to address clinical site issues with appropriate guidance and initiate corrective actions.

• Ability to apply functional expertise and exercise sound judgment.

• Demonstrated business ethics and integrity.

🏝️ Benefits

• Employees have the option to work remotely.

• An equal opportunity employer dedicated to operating with integrity, fostering innovation, transforming lives, and serving the community.