Company Description
The Milestone One Site Coordinator supports a medical institution in clinical trial related activities associated with assessment of feasibility of new potential clinical studies, assistance in patient flow at the institution in currently on-going clinical trials, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives in order to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution.
Job Description
Scope of responsibilities:
- Acts as the main line of communication between the Sponsor or CRO and the medical institution.
- Builds and maintains good rapport with the medical staff and with Sponsor or CRO representatives involved in clinical trials.
- Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
- Assists in scheduling, preparation and conduct of all types of monitoring visits at the medical institution.
- Actively participates in all types of monitoring visits conducted at the medical institution.
- Tracks enrollment and actively supports the medical site team in order to ensure enrollment targets are met at the site level.
- Maintains study specific and general tracking documents at the site level.
- Ensures accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
- Assists in timely reporting and follow up on Adverse Events, Serious Adverse Events and Protocol Deviations in full cooperation with the responsible CRA.
- Supports proper handling, accountability and reconciliation of all investigational products and clinical supplies.
- Collects and maintains all site-specific documents needed by the Sponsor or CRO for submission of the medical institution as a study site to the authorities.
- Facilitates and supports contract and budget negotiations at the site level.
- Oversees and manages Investigator and Site payments at the site level.
- Ensures that the medical site team participating in a clinical trial completes all necessary study specific and general training prior to their involvement into a clinical trial.
- Ensures on-going quality in clinical trials by ensuring that all study procedures are scheduled and conducted as per study requirements, as well as all data generated by the site is fully supported by source documents and is entered in a timely manner into study specific EDC systems.
- Actively participates in the preparation of the medical institution for a study site audit or inspection.
- Participates in the medical institution site audit or inspection, by actively supporting the medical site team as well as by directly addressing data entry and query related issues.
Qualifications
- A University degree in Life Science, preferably in pharmacy, nursing or lab analytics.
- Experience as Site Coordinator is required
- Certified GCP training
- Full proficiency in Polish and intermediate English language proficiency
- Proficiency in MS Office applications
- Valid category B driver’s license
Additional Information
This is a great opportunity for you to develop new skillsets, while growing with the company.
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
