Lead Site Coordinator

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

📋 Description

• Provide daily oversight and coordination for a team of up to 8 Site Coordinators/Site Administrators.

• Conduct training sessions on clinical trial protocols.

• Perform routine quality checks to ensure compliance with ICH GCP, procedures, and regulations.

• Offer operational support, troubleshooting, and backup assistance for site personnel.

• Assist in identifying clinical research opportunities and relevant research networks.

• Collaborate on negotiations regarding contracts and budgets.

• Supervise payments to Investigators, Sites, and MO1.

• Review and guarantee the timely and accurate entry of study-specific information into the MO1 CTMS.

• Monitor patient recruitment support and track enrollment targets.

• Foster communication among site teams, Milestone One, sponsors/CROs, and medical institution personnel.

• Prepare site teams for audits and inspections, providing on-site support as needed.

• Suggest and implement process enhancements and operational tools.

• Serve as the primary communication link between the Sponsor/CRO and the site.

• Address feasibility inquiries promptly.

• Organize and prepare for monitoring visits while supporting monitors during these visits.

• Track patient enrollment and assist in managing project timelines and enrollment objectives.

• Maintain documentation tracking for study-specific and general site records.

• Input data into study-specific EDC systems and resolve data clarification inquiries.

• Report and follow up on Adverse Events and Protocol Deviations.

• Manage, account for, and reconcile investigational products and clinical supplies.

• Gather and maintain site-specific regulatory documents.

• Facilitate contract and budget negotiations at the site level.

• Support payments to Investigators and Sites.

• Schedule or conduct study procedures in line with study requirements and delegated responsibilities.

• Prepare for and engage in onsite audits or regulatory inspections.

• Establish and maintain relationships with sponsors, CROs, and medical institutions.

⛳️ Requirements

• Please submit your CV in English.

• Hold a university degree in life sciences, pharmacy, nursing, lab analytics, or a related field (Master’s degree preferred).

• Completion of ICH GCP training.

• IATA certification is advantageous.

• At least 4 years of relevant experience in a clinical setting.

• Proficient in the local language.

• Minimum B2 level proficiency in English.

• Competence in MS Office applications.

• A valid category B driver's license.

• Familiarity with the role and lifecycle of essential study documents in ensuring clinical trial compliance and data integrity.

• Understanding of clinical trial data management processes and the utilization of external vendor-supported systems.

• Knowledge of eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient-Reported Outcomes) systems.

🏝️ Benefits

• Competitive salary package.

• Opportunities for professional development and training.

• Collaborative and supportive work environment.

• Health and wellness benefits.

• Flexible working arrangements.