Senior Clinical Research Associate – Oncology

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

📋 Description

• Oversee site qualification, initiation, monitoring, management, and closure activities in alignment with study protocols, Good Clinical Practice (GCP), and regulatory standards.

• Assess site performance and adherence to protocols while promoting high-quality, timely collection of clinical data.

• Act as a Lead Clinical Research Associate (CRA) on global studies, coordinating monitoring efforts and providing support to fellow CRAs as necessary.

• Examine source documentation, informed consent procedures, safety data, and case report forms to ensure data accuracy and safeguard patient well-being.

• Guide and instruct site staff and junior CRAs on study protocols, monitoring methodologies, and compliance with protocols.

• Collaborate with Project Management and study teams to monitor study progress, assess deliverables, and facilitate successful study execution.

• Prepare and evaluate monitoring reports, regulatory documentation, and essential study records, ensuring proper maintenance of the Trial Master File.

• Assist in organizing investigator meetings, training for study teams, bid defenses, and the creation of study-specific tools, plans, and templates.

• Maintain effective communication with investigative sites and offer ongoing support to ensure smooth study operations and resolution of queries.

• Provide support to sites throughout South Korea and travel to investigative sites approximately 8–10 days each month.

⛳️ Requirements

• Medical Doctor (MD) degree or Pharmacy degree with a minimum of 3 years of experience as a Clinical Research Associate; OR a four-year degree in a medical, biological, health, pharmacy, physical science, or related field with at least 5 years of Clinical Research Associate experience; OR a two-year college curriculum/equivalent education (preferably in nursing or life science) with a minimum of 7 years of Clinical Research Associate experience.

• In-depth knowledge of clinical research methodologies, monitoring practices, and site management operations.

• Strong understanding of FDA and/or EU regulations, ICH Guidelines, GCP, local regulatory standards, and clinical trial Standard Operating Procedures (SOPs).

• Proven experience in various therapeutic areas with the capability to operate as a Lead CRA.

• Proficient in Microsoft Office, electronic data capture (EDC) systems, and IxRS platforms.

• Exceptional communication, organizational, time management, problem-solving, and interpersonal abilities.

• Proficiency in English and fluency in the local language(s) required for the regions of responsibility.

• Experience in full-service monitoring is PREFERRED.

🏝️ Benefits

• Flexible home-based work arrangement.

• Opportunities for learning and professional development.

• Opportunities for leadership, mentorship, and strategic contributions.

• A collaborative and inclusive workplace environment.

• Professional growth through mentoring and training initiatives.