Clinical Research Associate II

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

📋 Description

• Proactively address clinical site issues related to studies and suggest corrective measures.

• Oversee clinical investigative sites to ensure compliance with protocols and successful execution of studies.

• Maintain adherence to regulations, ICH/GCP Guidelines, AbbVie Standard Operating Procedures, monitoring plans, and quality standards.

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

• Manage and influence site personnel to achieve study objectives, even without direct authority.

• Ensure readiness for regulatory inspections at assigned clinical sites.

• Guarantee the quality and timely submission of study data and reporting of safety events.

• Safeguard study subjects by ensuring compliance with monitoring plans, SOPs, guidelines, and regulations.

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

• Oversee investigator payments and negotiate agreements with investigators and hospitals.

• Complete expense reports in accordance with applicable guidelines.

• Identify, assess, and recommend new investigators and clinical research sites.

⛳️ Requirements

• Bachelor’s degree in a scientific or a related field.

• At least 1 year of experience in a clinically-related role.

• Preferred: 6 months of experience in clinical research monitoring.

• Required: Experience in on-site monitoring of investigational drug or device trials.

• Proficient in English, both written and spoken.

• Comprehensive knowledge of therapeutic indications pertinent to clinical trials.

• Thorough understanding of clinical research regulations, ICH/GCP Guidelines, and relevant regulations.

• Strong organizational and planning skills.

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

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

• Strong analytical and conceptual skills.

• Excellent interpersonal and communication abilities.

• Skill in addressing clinical site issues and initiating corrective actions while communicating them effectively.

• Ability to apply functional expertise and exercise sound judgment.

• Proven business ethics and integrity.

🏝️ Benefits

• Option for remote work.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants in the US & Puerto Rico.

• Protections for Veterans and individuals with disabilities in employment.