Clinical Research Associate – Site Director

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

📋 Description

• Accountable for the effective initiation, oversight, and execution of Phase I-IV trials at designated clinical sites.

• Conduct clinical site management and monitoring tasks in line with ICH-GCP guidelines, SOPs, local laws and regulations, study protocols, related study plans, and operational guidelines.

• Act as the primary liaison for clinical sites throughout all phases, from initiation to the closure of clinical studies.

• Organize monitoring availability and ensure adherence to data entry timelines at designated sites, performing necessary monitoring, including source data verification, to guarantee that site activities are executed within established timeframes.

• Build and nurture strong relationships with sites while ensuring the continuity of these relationships.

• Engage with investigators and site personnel regarding issues related to protocol execution, recruitment, protocol deviations, readiness for inspections, and overall site performance.

• Recognize, evaluate, escalate, and address site performance or quality issues promptly.

• Carry out feasibility and site identification tasks for new clinical studies.

• Manage start-up and maintenance activities for assigned sites, including the preparation and collection of essential documents necessary for regulatory and IRB/EC submissions (initial and amendments).

• Promote communication with relevant site staff involved in start-up and IRB/EC submissions.

• Support site budget and contract negotiations and ensure timely finalization of required clinical trial agreements for designated sites in collaboration with clinical program management and finance.

• Responsible for developing site-specific recruitment, retention, and follow-up strategies.

• Assist and support investigator site audits and/or inspection activities as necessary.

• Conduct remote data reviews and resolve queries for designated sites.

• Enhance the overall knowledge of the clinical operations team by sharing best practices and engaging in improvement initiatives.

• Provide coaching and mentoring to colleagues as needed.

• Contribute to the evaluation of Codera’s systems and procedures as required.

• May participate in other areas of study management and staff training when necessary.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s Degree in a Life Science discipline is required.

• A Bachelor’s degree in nursing or RN is advantageous.

• At least 3 years of direct site monitoring experience is essential.

• Bilingual proficiency in English and French is required.

• Comprehensive understanding of all facets of clinical site monitoring and overall drug development is necessary.

• In-depth knowledge of FDA, ICH, and GCP guidelines, along with applicable local regulations, is required.

• Exceptional critical thinking skills with the ability to comprehend complex patient histories, medical terminology, and treatment landscapes.

• Capability to interpret study-level metrics data and proactively identify and mitigate risks throughout the study lifecycle.

• Detail-oriented, organized, and dedicated to maintaining quality and consistency.

• Results-oriented with the ability to manage competing high-priority tasks, demonstrating a proven ability to achieve deliverables within defined timelines.

• Strong team interaction skills and the capacity to work effectively in team environments.

• Ability to function in a dynamic setting with a high degree of adaptability.

• Willingness to contribute to a culture of process improvement, focusing on streamlining processes to add value to the company's business needs.

• Excellent written and verbal communication abilities.

• Experience and demonstrated proficiency in CTMS and eTMF systems is preferred.

• Must be willing and able to travel up to 50-65%.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.