Lead Site Coordinator

🔥 11 hours ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Provide day-to-day oversight and coordination for up to 8 Site Coordinators/Site Administrators • Conduct trainings on clinical trial procedures • Conduct regular quality checks for compliance with ICH GCP, procedures, and regulations • Provide operational support, troubleshooting, and backup for site staff • Support identification of clinical research opportunities and relevant research networks • Collaborate on contract and budget negotiations • Oversee Investigator, Site, and MO1 payments • Review and ensure timely, accurate study-specific information entry into the MO1 CTMS • Monitor patient recruitment support and enrollment targets • Promote communication among site teams, Milestone One, sponsors/CROs, and medical institution staff • Prepare site teams for audits and inspections and provide on-site support • Propose and implement process improvements and operational tools • Act as the main communication line between Sponsor/CRO and the site • Respond to feasibility questions in due time • Schedule and prepare for monitoring visits and support monitors during visits • Track patient enrollment and support project timelines and enrollment goals • Maintain study-specific and general site document tracking • Enter data into study-specific EDC systems and resolve data clarification queries • Report and follow up on Adverse Events and Protocol Deviations • Handle, account for, and reconcile investigational products and clinical supplies • Collect and maintain site-specific regulatory documents • Facilitate site-level contract and budget negotiations • Support Investigator and Site payments • Schedule or perform study procedures according to study requirements and delegated responsibilities • Prepare for and participate in onsite audits or regulatory inspections • Build and sustain relationships with sponsors, CROs, and medical institutions

🎯 Requirements

• Please submit CV in English • University degree in life science, pharmacy, nursing, lab analytics or related (Master’s degree preferred) • ICH GCP training • IATA certification is an asset • Minimum 4 years of on-the-job experience in a clinical environment • Fluent use of local language • At least B2 level of English • Proficiency in MS Office • Valid category B driver’s license • Knowledge of 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 use of external vendor-supported systems • Knowledge of eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient-Reported Outcomes) systems

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