Site Coordinator

The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICH-GCP protocol requirements within Study specific defined timelines and enrollment goals.

The function of the role may include but not limited to any/all of the following:

• 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.

Qualifications :

• A university degree in Life Science preferably in pharmacy nursing or lab analytics.
• Minimum of 2 years of on-the-job experience as a site coordinator
• Ability to work in a fast-paced environment with short timelines and multiple tasks to be completed simultaneously.
• Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.
• Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
• Fluent Polish and English

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1