Clinical Research Associate 2

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

📋 Description

• Oversee clinical investigative sites for AbbVie clinical trials.

• Ensure adherence to protocols, regulatory standards, GCP/ICH guidelines, SOP compliance, and quality benchmarks.

• Carry out site qualification, initiation, interim monitoring, and study closure visits for Phase 1–4 trials.

• Guide and influence site staff to achieve study goals.

• Proactively manage sites and execute action plans to ensure compliance.

• Maintain readiness for regulatory inspections at designated clinical sites.

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

• Safeguard study participants by adhering to monitoring plans, SOPs, guidelines, and regulations.

• Provide training to site personnel on protocols and regulatory requirements.

• Administer investigator payments in line with contracts.

• Negotiate agreements with investigators and hospitals alongside stakeholders.

• Complete expense reports in accordance with applicable guidelines.

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

⛳️ Requirements

• Preferred tertiary qualification in a health-related field, such as Medical, Scientific, or Nursing.

• At least 2 years of relevant clinical experience.

• Minimum of 1 year of independent monitoring experience.

• Experience in independently conducting monitoring visits is preferred.

• Comprehensive understanding of therapeutic indications pertinent to clinical trials.

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

• Excellent planning and organizational abilities.

• Capability to function effectively in a dynamic environment with multiple projects and deadlines.

• Ability to comprehend and adhere to work processes within the assigned role.

• Strong analytical and conceptual skills.

• Exceptional interpersonal and communication abilities.

• Proficient in addressing clinical site challenges with appropriate guidance and initiating corrective actions.

• Ability to leverage functional expertise and apply sound judgment.

• Demonstrated business ethics and integrity.

🏝️ Benefits

• Option for remote work.

• Commitment to equal opportunity employment.

• Reasonable accommodations for applicants from the US & Puerto Rico.