Senior Clinical Research Associate (Oncology)

TL;DR

Senior Clinical Research Associate (Oncology): Managing study sites and ensuring patient safety and data quality in clinical research studies with an accent on oncology and rare diseases. Focus on conducting site visits, verifying informed consent, and ensuring adherence to ICH-GCP and regulatory guidelines.

Location: Remote, South Korea (60-70% travel required)

Company

hirify.global is a CRO that integrates clinical trial execution with deep scientific knowledge and advanced data sciences to improve the success rate of bringing life-changing therapies to patients.

What you will do

• Oversee all aspects of study site management to ensure patient safety and high data quality.
• Conduct all forms of site visits, including qualification, initiation, routine monitoring, and close-out visits.
• Manage site start-up procedures, including feasibility, recruitment of investigators, and regulatory submissions.
• Verify informed consent processes and assess factors affecting subject safety and data integrity.
• Perform investigational product (IP) inventory, reconciliation, and security reviews.
• Identify and process Serious Adverse Events (SAEs) and escalate site risks to project management.

Requirements

• Bachelor's degree in a business, scientific, or healthcare discipline.
• Minimum 2 years of on-site monitoring experience.
• Must be based in South Korea.
• Fluency in English (C1), both verbal and written.
• Working knowledge of the drug development process and ICH-GCP guidelines.
• Willingness to travel 60-70% of the time.

Nice to have

• 1 year of oncology experience.
• Solid experience in clinical research or related fields.
• Excellent organizational skills and ability to work efficiently in a remote environment.

Culture & Benefits

• Opportunity to work with groundbreaking cancer therapies.
• Culture where employee contributions are appreciated and ideas are nurtured.
• Commitment to professional performance consistent with Precision Principles.
• Equal Opportunity Employer providing a diverse and inclusive work environment.