Freelance Site Coordinator

PSI CRO; Roma; In loco; EUR 50.000 - 70.000; Part-time

Descrizione del lavoro

An established industry player is seeking a dedicated Site Coordinator to support clinical trials and enhance study delivery. In this part-time role, you'll be the key liaison between the clinical study site and sponsors, ensuring effective communication and timely responses to feasibility questions. Your expertise will help track patient enrollment and maintain study documentation, contributing to the overall success of clinical projects. If you thrive in dynamic environments and are passionate about supporting clinical research, this opportunity offers a chance to make a significant impact in a supportive and people-focused organization.

Competenze

• Minimum of 2 years experience as a Site Coordinator required.
• Ability to work in a fast-paced environment with multiple tasks.

Mansioni

• Act as main communication line between Sponsor and site.
• Track patient enrollment and support project timelines.
• Prepare for and participate in onsite audits and inspections.

Conoscenze

Effective Communication

Problem-Solving

Time Management

Data Entry

Formazione

University Degree in Life Science

Pharmacy, Nursing or Lab Analytics

Strumenti

EDC Systems

Descrizione del lavoro

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.

This is a part time assignment for 0.5 FTE.

• Act as the main line of communication between the Sponsor or CRO and the site.
• Ensure responses 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.
• Valid US Driver's License with the ability to travel as needed.
• Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.

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.