Company 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 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.
Qualifications
- 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.
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.
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
