Lead Site Coordinator

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

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

• Provides day-to-day oversight and coordination for a team of up to 8 Site Coordinators/ Site Administrators, ensuring alignment with project goals, operational standards, and quality expectations. • Conducts trainings to Site Coordinators/Administrators on clinical trial procedures, ensuring they have the necessary knowledge, skills, and tools to support study operations effectively. • Conducts regular quality checks on the work performed by Site Coordinators and Site Administrators to ensure tasks are completed in compliance with ICH GCP, relevant procedures, and applicable regulations. • Acts as the first line of operational support for Site Coordinators and Site Administrators, providing hands-on assistance and troubleshooting to resolve study-related issues promptly. • Supports management in identifying clinical research opportunities by sharing information on available trial pipelines and relevant research networks. • Collaborates with other team members during contract and budget negotiations; oversee Investigator, Site and MO1 payments utilizing MO1 tools to ensure timely contract execution and payment processing in alignment with agreed timelines. • Reviews and ensures timely and complete entry of study-specific information into the MO1 CTMS for the sites assigned to Site Coordinators, ensuring accuracy and compliance with study timelines and requirements. • Monitors Site Coordinators' support of patient recruitment activities to help achieve enrollment targets. • Promotes effective communication and collaboration between the site team, Milestone One team, and Medical Institution staff by safeguarding the timely flow of essential information and supporting a positive working environment. • Contributes to the preparation of the site team for audits and inspections by ensuring operational readiness and providing on-site support during these activities. • Fosters continuous improvement in site operations by proposing process enhancements and supporting the implementation of new operational tools and practices. • Act as the main line of communication between the Sponsor or CRO and the site. • Ensure response to feasibility questions are provided in due time. • Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center. • Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution. • Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals. • Maintain study specific and general tracking of documents at the site level. • Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site. • Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations. • Proper handling, accountability and reconciliation of investigational products and clinical supplies. • Collect, handle and maintain all site-specific regulatory documents as needed. • Facilitate and support the contract and budget negotiations at the site level. • Support Investigator and Site payments and processes as needed. • Schedule and/or perform study procedures as per study requirements and delegation of responsibilities. • Prepare for and participate in onsite study audits or regulatory agency inspections. • Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • Professional development opportunities