Clinical Research Associate II

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

📋 Description

• Proactively anticipate and resolve clinical site issues related to studies.

• Initiate, suggest, and convey corrective actions to ensure successful protocol implementation.

• Oversee clinical investigative sites to ensure compliance with protocols, regulations, ICH/GCP Guidelines, AbbVie SOPs, monitoring plans, and quality standards.

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

• Supervise site personnel activities and guide them to achieve study goals.

• Manage sites and execute action plans to guarantee compliance.

• Maintain regulatory inspection readiness at assigned clinical sites.

• Ensure the quality and timeliness of study-site data submissions.

• Guarantee appropriate reporting and follow-up regarding safety events.

• Safeguard the safety and protection of study participants.

• Train study site staff on protocols and regulatory requirements.

• Manage investigator payments in line with executed contracts.

• Negotiate agreements with investigators and hospitals alongside stakeholders.

• Complete expense reports in accordance with local and applicable guidelines.

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

⛳️ Requirements

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

• At least 1 year of clinically-related experience is required.

• Preference for candidates with 6 months of clinical research monitoring experience.

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

• Proficient in English, both written and spoken.

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

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

• Excellent planning and organizational abilities.

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

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

• Strong analytical and conceptual skills.

• Exceptional interpersonal and communication abilities.

• Capable of addressing clinical site challenges and implementing corrective actions.

• Ability to leverage functional expertise and demonstrate sound judgment.

• Proven business ethics and integrity.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Commitment to integrity, innovation, community service, and transforming lives.