Clinical Research Associate – FSP

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

📋 Description

• Ensure the proper execution of clinical trials in accordance with the Study Monitoring Plan, relevant laws, GCP, and client standards.

• Oversee clinical trial operations at designated investigator sites from activation through database closure.

• Act as the primary contact for assigned investigator sites and escalate issues to the SCP as necessary.

• Facilitate communication among study team members, vendors, and investigator sites.

• Conduct investigator site development, coaching, training, and protocol instruction.

• Participate in investigator meetings and assist with enrollment, site activation, and recruitment efforts.

• Perform onsite and remote/electronic monitoring for site initiation, routine checks, and site closure.

• Monitor adverse events and serious adverse events while collaborating with the Drug Safety Unit.

• Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supplies, study progress, and metric updates.

• Identify and rectify site issues and formulate corrective and preventive actions.

• Address data queries and execute investigator site close-out procedures.

• Oversee receipt, handling, accounting, storage, and destruction of investigational products.

• Support database release and act as an unblinded monitor when necessary.

• Maintain knowledge of products, protocols, and therapy areas while ensuring patient safety and eligibility.

• Drive remediation of Quality Events and audit observation CAPA activities when required.

• Collaborate with SCP, Country Study Operations Manager, clinicians, recruitment specialists, and clinical data scientists.

• Mentor and train Clinical Research Associates and Sr CRA I as needed.

• Adhere to required training, timesheets, expense reports, CV updates, Parexel processes, ICH-GCP, and applicable regulations.

⛳️ Requirements

• At least 3 years of relevant experience in clinical research site monitoring.

• Comprehensive knowledge of clinical trial methodologies, ICH/GCP, and local country regulations.

• Preferable therapeutic experience in Oncology (mandatory), Vaccines, Internal Medicine, or Infectious Diseases.

• Experience with global clinical trials.

• Proficient in English and the native language(s) of the country in which they will be working.

• Significant travel is necessary.

• Proven knowledge of clinical research and development processes.

• Familiarity with both global and local regulatory requirements.

• Understanding of monitoring, data acquisition and cleaning, reporting, and other operational aspects of clinical research.

• Knowledge of disease and technical areas related to clinical studies, investigational products, and their respective development plans.

• Proven ability to support sponsor regulatory interactions and inspections.

• Knowledge of protocol design and feasibility assessment processes.

• Understanding of regional/country culture and medical practices and their influence on clinical trial delivery.

• Ability to work in a matrix team environment and influence, lead, and collaborate with others for successful clinical trial outcomes.

• Skills in evaluating, interpreting, and presenting complex issues and data for risk management and mitigation.

• Strong verbal and written communication abilities.

• Bachelor's degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent.

🏝️ Benefits

• Opportunity to work with a diverse and talented team.

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Professional development and training opportunities.

• Flexible working arrangements.