PSI CRO AG logo
PSI CRO AG

The global CRO where clinical trials run on time.

Lead Site Coordinator

GeneralGeneralFull TimeRemoteSeniorTeam 1,001-5,000Since 1996H1B No SponsorCompany SiteLinkedIn

Location

Turkey

Posted

9 hours ago

Salary

0

Seniority

Senior

Postgraduate Degree4 yrs expEnglishGoogle Cloud Platform

Job Description

Lead Site Coordinator

PSI CRO AG

• 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).

Job 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

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