Clinical Trial Coordinator
il y a 1 mois
Job Title: Site Coordinator
The Site Coordinator role at PSI is a key position that supports a Clinical Study Site in clinical trial-related activities according to ICH-GCP and protocol requirements. This role is responsible for ensuring timely responses to feasibility questions, scheduling and preparation for monitoring visits, and tracking patient enrollment to meet project timelines and enrollment goals.
Key Responsibilities:
- Act as the main point of contact between the Sponsor or CRO and the site.
- Ensure timely responses to feasibility questions.
- Assist in scheduling and preparation for monitoring visits.
- Be present and available to respond to monitors during monitoring visits.
- Track patient enrollment and 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.
- Accurately and timely enter data into study-specific EDC systems and resolve data clarification queries.
- Timely report and follow up on Reportable Adverse Events and Protocol Deviations.
- Properly handle, account for, and reconcile investigational products and clinical supplies.
- Collect, handle, and maintain site-specific regulatory documents as needed.
- Facilitate and support 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.
Qualifications:
- A university degree in Life Science, preferably in pharmacy, nursing, or lab analytics.
- Minimum of 2 years of on-the-job experience in a clinical trial environment, with relevant experience gained in clinical trials, clinical terminology, and medical research.
- Full working proficiency in French and 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 problem-solving skills.
- Valid Driver's License with the ability to travel as needed.
- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
Additional Information:
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