The Lead Site Coordinator (LSC) works as an integral part of the Operations team supporting clinical trial activities at assigned medical institutions. The LSC coordinates site-specific operational processes, ensures smooth patient logistics, assists with feasibility assessments, and serves as the primary point of contact for routine site support activities. The LSC collaborates closely with the site team, Sponsor/CRO representatives, and internal Milestone One (MO1) functions to ensure the quality, compliance, and timely execution of clinical trials in accordance with ICH GCP, applicable regulations, and clinical protocols.
The LSC is responsible for coordinating, supporting and mentoring Site Coordinators and Site Administrators on site-specific activities. LSC ensures continuity and high quality of work performed by Site Coordinators and Administrators, provides assistance and backup, when necessary, and resolves specific issues to support effective clinical research activities of the sites in accordance with ICH GCP, relevant procedures and legislation, as well as the clinical protocol.
Lead Site Coordinator also acts as a mentor, team lead, and a backup for Site Coordinators and Site Administrators, ensuring their continuous development and effective performance.
In this role you will:
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).
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.
If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.