Site Coordinator

Milestone One; Olsztyn; On-site; PLN 55,000 - 75,000; Full time

Job summary

Milestone One is seeking a Site Coordinator to support a Clinical Study Site in trial-related activities in line with ICH-GCP and protocol requirements within defined timelines and enrollment goals.

The role involves acting as the main liaison between Sponsor/CRO and the site, coordinating monitoring visits, tracking enrollment, data entry into EDC systems, and assisting with audits and regulatory compliance to ensure study success.

Qualifications

• Minimum 2 years of site coordinator experience.
• University degree in Life Science (pharmacy/nursing/lab analytics preferred).
• Fluent in Polish and English.
• Ability to work in a fast-paced environment with multiple tasks.

Responsibilities

• Act as the main line of communication between Sponsor or CRO and the site.
• Ensure timely responses to feasibility questions.
• Assist in scheduling and preparing monitoring visits at the site.
• Be present and available to respond to monitors during visits.
• Track patient enrollment and support timelines and enrollment goals.
• Maintain study-specific and general document tracking at the site level.
• Accurate data entry into study EDC systems and resolve data clarifications.
• Timely reporting of adverse events and protocol deviations.
• Handle investigational products and clinical supplies with care.
• Collect and maintain site regulatory documents as needed.
• Support contract and budget negotiations at the site level.
• Assist Investigator and site payments and processes as needed.
• Schedule and perform study procedures per protocol requirements.
• Prepare for and participate in onsite audits or inspections.

Skills

Fast-paced work

Multitasking

Effective communication

Problem-solving

Flexible hours

Polish and English fluency

Education

Life Science degree

Job description

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

Job Description

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:

• Actas the main line of communication between the Sponsor or CRO and the site.
• Ensureresponse to feasibility questions are provided in due time.
• Assistin scheduling and preparation for all types of monitoring visits at the medical institution/research center.
• Be present and available to respond to monitors duringall types of monitoring visits conducted at the medical institution.
• Trackpatient enrollment and actively supportthe medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
• Maintainstudy 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, handleand maintainall site-specific regulatory documents as needed.
• Facilitateand support the contract and budget negotiations at the site level.
• SupportInvestigator and Site payments and processes as needed.
• Scheduleand/or performstudy procedures as per study requirements and delegation of responsibilities.
• Preparefor and participatein 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.