Clinical Trials Site Coordinator

At Milestone One, our mission is to bring clinical trials to much wider populations of sites and patients around the world. For too long, clinical trials have only been available to a handful of patients at a handful of hospitals - a unique opportunity for selected few. Imagine every patient with no hope of a cure having the option of getting access to clinical research enabled by their physician and hospital.

Founded by a team of seasoned professionals with more than 30-years of global industry experience, we bring together driven and dedicated people around the world, working collectively to help make a positive impact on patient lives. Milestone One partners with research sites to navigate the complexities of clinical trials seamlessly. From medical equipment rental services to patient support services, we provide end-to-end support tailored to each site's unique needs empowering them to focus on what truly matters — delivering innovative therapies to patients.

Outstanding quality is at the heart of Milestone One. We hire only the best professionals on the market: experienced, engaged, open for development. Not only excellent specialists but also reliable and supportive teammates – we care not only about our clients but also about our team

• As a Site Coordinator at Milestone One, you are a crucial part of the breakthrough of bringing innovative therapies to a wider population of patients in need.
• Opportunities to gain experience in various therapeutic areas and within the company structure.
• Private medical care at Enel-Med, Luxmed, and Centrum Medyczne Damiana. The sponsored package covers also full dental care.
• Flexible benefit fund of 650 PLN per month that you can accommodate to your own needs: on sports card, lunch card (Sodexo), online shopping or entertainment.
• 4 extra paid leave days per year.
• Team building events.

You will join the operations team and will work on site, cooperating closely with medical staff, CRO or sponsor, and communicating with the patients, to make sure the study runs smoothly, on time, and according to the protocol, guidelines and regulations. You will work independently and be in charge of your own tasks. You will report directly to a Site Lead who will also be your first line of support on all work-related issues.

In this role you will:

• 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.

This job is for you if you're independent, a natural problem-solver, and deeply passionate about assisting health care communities in delivering life-changing treatments to patients. You must have a college or university degree in Life Sciences and a minimum of 2 years of experience as a Study Coordinator on site.

Flexibility in working hours and sites may be required depending on the schedule of study procedures and/or patient visits.

We value your time, so the recruitment process is short and remote - to the extent possible. Only one face-to-face meeting is required to actually get to know each other.

Our recruitment process includes:

• Analysis of applications.
• HR interview – remote, around 30 minutes – high level discussion of your experience, expectations of the role and command of English (you'll work in Polish on the site but we are an international company and you'll need to speak English to have development opportunities).
• Operations interview – face-to-face in Warsaw with an Operations team member (Site Lead and/or Sites Manager), around 1 hour – this is a more detailed discussion to check your practical knowledge of trial management on the site and provide you with all additional information you may still need after the 1st stage.
• Presenting the offer and signing the agreement – this can be done remotely.

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.