Site Coordinator

Milestone One AG; Olsztyn; On-site; PLN 80,000 - 110,000; Full time

Job summary

Milestone One is seeking a Site Coordinator to support a Clinical Study Site in trial activities in line with ICH-GCP and study timelines. You will act as the key liaison between the Sponsor or CRO and the site, assist with monitoring visits, track patient enrollment, and ensure timely data entry and regulatory documentation.

The role requires a Life Science degree and at least 2 years of onsite site coordination experience, with fluent Polish and English and flexibility to accommodate study

Qualifications

• Bachelor-level degree in Life Science or related field is required.
• At least 2 years of on-the-job experience as a site coordinator.
• Ability to work in a fast-paced environment with tight timelines.
• Strong communication skills under pressure and in stressful situations.
• Flexible hours may be required depending on study procedures and patient visits.
• Fluent in Polish and English.

Responsibilities

• Act as the main line of communication between Sponsor/CRO and the site.
• Support scheduling and preparation for monitoring visits at the medical institution/research center.
• Be present to respond to monitors during monitoring visits.
• Track patient enrollment and support timelines and enrollment goals.
• Maintain study documents and accurate data entry into EDC systems.
• Report and follow up on adverse events and protocol deviations.
• Handle, reconcile investigational products and clinical supplies.
• Maintain site regulatory documents and assist with contract/budget negotiations.

Skills

Fast-paced environment

Stress management

Problem solving

Multi-tasking

Effective communication

Flexible hours

Polish language

English language

Education

Life Science degree (pharmacy/nursing/lab analytics)

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:

• 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.