The Milestone One Site Coordinator role supports Clinical Study Sites in clinical trial related activities according to ICH-GCP, local regulations, 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 / CRO and the site.
- Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center, participation during all such visits.
- 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 assistance in 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 reconciliations 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.
- A university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
- An adequate combination of relevant on the job experience, education and training that confirms the availability of the knowledge, experience, skills and abilities required for the position may be considered.
- Minimum of 2 years of on-the-job experience in a clinical trial environment, where relevant experience has been gained in clinical trials, clinical terminology, and medical research working in the role of a Study Coordinator or similar function.
- Full working proficiency in Romanian & English
- 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.
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.
