Lead Site Coordinator

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Provides daily supervision and coordination for a team of up to 8 Site Coordinators/Site Administrators, ensuring alignment with project objectives, operational standards, and quality expectations.

• Conducts training sessions for Site Coordinators/Administrators on clinical trial procedures, equipping them with the necessary knowledge, skills, and tools to effectively support study operations.

• Performs regular quality assessments on the work carried out by Site Coordinators and Site Administrators to ensure task completion in accordance with ICH GCP, relevant procedures, and applicable regulations.

• Serves as the primary operational support for Site Coordinators and Site Administrators, offering hands-on assistance and troubleshooting to promptly resolve study-related issues.

• Assists management in pinpointing clinical research opportunities by sharing information regarding available trial pipelines and pertinent research networks.

• Collaborates with other team members during contract and budget negotiations; oversees Investigator, Site, and MO1 payments utilizing MO1 tools to guarantee timely contract execution and payment processing in line with agreed timelines.

• Reviews and ensures the timely and complete entry of study-specific information into the MO1 CTMS for the sites assigned to Site Coordinators, ensuring accuracy and adherence to study timelines and requirements.

• Monitors Site Coordinators' support of patient recruitment activities to help meet enrollment targets.

• Encourages effective communication and collaboration between the site team, Milestone One team, and Medical Institution staff by ensuring the timely flow of essential information and fostering a positive working environment.

• Aids in preparing the site team for audits and inspections by ensuring operational readiness and providing on-site support during these activities.

• Promotes continuous improvement in site operations by suggesting process enhancements and assisting in the implementation of new operational tools and practices.

• Acts as the main point of contact between the Sponsor or CRO and the site.

• Ensures timely responses to feasibility questions.

• Assists in scheduling and preparing for all types of monitoring visits at the medical institution/research center.

• Remains present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.

• Tracks patient enrollment and actively supports the medical site and CRO/Sponsor team in achieving project timelines and enrollment goals.

• Maintains study-specific and general tracking of documents at the site level.

• Ensures accurate and timely data entry into study-specific EDC systems and resolves data clarification queries issued for the site in a timely manner.

• Reports and follows up on Reportable Adverse Events and Protocol Deviations promptly.

• Properly handles, accounts for, and reconciles investigational products and clinical supplies.

• Collects, manages, and maintains all site-specific regulatory documents as necessary.

• Facilitates and supports contract and budget negotiations at the site level.

• Assists with Investigator and Site payments and processes as required.

• Schedules and/or performs study procedures in accordance with study requirements and delegated responsibilities.

• Prepares for and participates in on-site study audits or regulatory agency inspections.

• Builds and maintains long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).

⛳️ Requirements

• University degree in life sciences, pharmacy, nursing, lab analytics, or a related field (Master’s degree preferred)

• ICH GCP training

• IATA certification is a plus

• Minimum of 4 years of practical experience in a clinical setting

• Fluent in the local language, with at least a B2 level of proficiency in English

• Proficient in MS Office

• Valid category B driver’s license

• Understanding of the role and lifecycle of essential study documents in ensuring clinical trial compliance and data integrity.

• Familiarity with clinical trial data management processes and the use of vendor-supported external systems.

• Knowledge of eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient-Reported Outcomes) systems.

🏝️ Benefits

• Health insurance

• Professional development opportunities