Regional Lead Site Coordinator

Job Description

We are a fast‑growing Site Enabling Organization operating globally in the field of clinical research. We are driven by quality, teamwork, and innovation. As we continue to expand our global operations, we are seeking a passionate and dedicated Lead Site Coordinator to join our Operations Team.

The Lead Site/Study Coordinator supports an assigned group of medical institutions for activities involving clinical trial conduct. Support for staff on protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Supervise tasks assigned to site level staff may include activities related to feasibility assessment, research visit coordination, logistics of scheduling, collaboration with ancillary departments, general study conduct tasks, data entry into study-related EDC systems, and interaction with CRO or sponsor representatives to schedule monitoring visits.

Additional duties include compliance monitoring, mentoring staff, developing protocol-specific tools, and administering training programs.

• Acts as a constant line of communication between the assigned Milestone One Manager, site staff, and the Sponsor or CRO.
• Acts as a liaison recruiting new site partners.
• Acts as a resource for identifying new vendors for activities not provided by the medical institution.
• Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
• Assists with identifying new projects within the interests of the medical institution and/or areas in which there is a medical need to better serve the needs of Milestone One and the clinical site partner.
• Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the inclusion and exclusion criteria.
• Performs site quality checks to confirm compliance with the protocols and Milestone One SOPs.
• Assists with plan development for new recruitment and retention tools, source documentation, and other site tools to enhance quality and time management of research staff.
• Evaluates protocols and develops recruitment strategies to enhance enrollment.
• Provides training to Milestone One and site staff regarding clinical research best practices and study-specific processes.
• Participates in the development and deployment of the Milestone Site/Study Coordinator Training Program.
• Assists the local research team in standard clinical research procedures and tasks, developing a site plan to efficiently incorporate clinical trials into the investigative site clinical practice with minimal interruption.
• Assists in scheduling and preparation for all types of sponsor or CRO representative visits at the medical institution as needed.
• Tracks patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level, providing regular updates to staff and investigators regarding study amendments as needed.
• Ensures accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
• Supports proper handling, accountability, and reconciliation of all investigational products and clinical supplies.
• Supports the contract and budget negotiations and oversees Investigator/Site payments. Develops new mechanisms that may reduce costs for Milestone One and/or increase revenue for site partners.
• Ensures that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement. Retraining will be completed for changes to the protocol before site implementation as needed.
• Participates in maintaining study documents at the medical institution in preparation for on-site study visits or regulatory agency inspections, performing a site readiness inspection prior to any sponsor/CRO or regulatory inspections.
• Assists with preparing and submitting regulatory documents and…