Job Description

• 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.
• Facilitates and participates in sponsor or CRO representatives' visits to the medical institution.
• May be involved in the on-site training of CRAs as well as Study Coordinators as part of the Milestone One or other education programs.
• At the discretion of the Milestone One Line Manager responsible, may be assigned other tasks related to the operation of Milestone One.

Qualifications

Education and experience:
- A university degree in Life Science, preferably in pharmacy, nursing or lab analytics or an adequate combination of relevant on the job experience, education and training that confirms the required knowledge, skills and abilities for the position of the Milestone One Site Coordinator. This is defined as a minimum of 2 years of on-the-job experience in a clinical environment, where relevant experience has been gained in clinical trials, clinical terminology and medical research.
Training and skills:
- Certified GCP training
- Introductory training in SOPs adequate for the position of the Milestone One Site Coordinator.
- Customized on the job training within the initial 2 weeks of work conducted under the supervision of the Milestone One Line Manager or a designated person.
certificate or demonstrated at the job interview.
Computer skills:
- Basic proficiency in MS Word
- Basic proficiency in MS Excel
- Basic proficiency in MS PowerPoint
- Basic proficiency in MS Outlook
Other:
- Valid category B driver’s license
- Non-standard working hours dependent of study patient visits and scheduled study procedures.