Site Care Partner – Senior/Lead CRA

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

📋 Description

• Qualify and activate designated clinical trial sites.

• Assist in country and site selection, including site list evaluation and qualification.

• Provide insights on protocol feasibility, standard care, and medical practices for the country/region.

• Execute site start-up activities, such as site qualification, coordinating activation checklists, finalizing ICF, and conducting SIV.

• Organize site activation training and ensure all required documentation and systems are in place.

• Conduct follow-ups post-qualification and SIV to confirm site readiness for FSFV.

• Collaborate with CRAs to guarantee site monitoring preparedness and successful enrollment delivery.

• Cultivate and sustain relationships with site organizations, strategic partners, investigators, and site personnel.

• Address escalated site delivery challenges involving vendors, contracts, and payments.

• Oversee investigational product and ancillary supply strategies throughout the study's lifecycle.

• Assist in recruitment planning and achieving global, country, and local targets.

• Collaborate with regulatory bodies and study start-up teams to finalize country and local registry tasks.

• Provide recommendations and insights regarding site performance, requirements, processes, and practices for the country/region.

• Assist with import/export requirements for investigational products and ancillary supplies.

• Review site reports and associated issues.

• Ensure quality and consistency in monitoring delivery.

• Support CRA relationships with investigators and escalate any training or compliance issues.

• Complete all necessary training, timesheets, expense reports, and CV updates.

• Adhere to Parexel processes, ICH-GCP, and relevant regulations.

⛳️ Requirements

• A minimum of 8+ years of CRA experience.

• Experience with oncology studies.

• Experience in additional therapeutic areas is an advantage.

• Familiarity with Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.

• Proficient computer skills and willingness to adopt new technologies.

• Ability to manage necessary travel.

• Understanding of country-specific GCP requirements.

• Proven experience in site management with prior CRA background.

• Demonstrated experience in start-up activities up to site activation.

• Proven experience in conduct and close-out activities.

• In-depth knowledge of quality and regulatory standards in relevant countries.

• Bachelor's degree or RN in a related field, or an equivalent combination of education, training, and experience (minimum of 5 years’ experience).

• Proficiency in English is required; knowledge of the local language is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday leave.

• Opportunities for professional development and career advancement.

• Flexible working hours and the possibility of remote work.