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Clinical Study Site Coordinator
Il y a 3 mois
Job Overview
The Clinical Study Site Coordinator position at PSI is essential for supporting a Clinical Study Site in the execution of clinical trial activities in accordance with ICH-GCP guidelines and specific protocol requirements, all while adhering to defined timelines and enrollment objectives.
The responsibilities of this role encompass, but are not limited to, the following:
- Serve as the primary communication link between the Sponsor or CRO and the clinical site.
- Ensure timely responses to feasibility inquiries.
- Assist in the scheduling and preparation for various monitoring visits at the research facility.
- Be present and available to address monitors during all types of monitoring visits conducted at the site.
- Monitor patient enrollment and actively collaborate with the medical site and CRO/Sponsor team to achieve project timelines and enrollment targets.
- Maintain accurate study-specific and general documentation tracking at the site level.
- Perform precise and timely data entry into study-specific EDC systems and resolve data clarification queries promptly.
- Report and follow up on Reportable Adverse Events and Protocol Deviations in a timely manner.
- Ensure proper handling, accountability, and reconciliation of investigational products and clinical supplies.
- Collect, manage, and maintain all site-specific regulatory documents as required.
- Facilitate and support contract and budget negotiations at the site level.
- Assist with Investigator and Site payments and processes as necessary.
- Schedule and/or conduct study procedures in accordance with study requirements and delegated responsibilities.
- Prepare for and participate in onsite study audits or regulatory agency inspections.
Required Qualifications
- A university degree in Life Sciences, preferably in pharmacy, nursing, or laboratory analytics. A suitable combination of relevant experience, education, and training that demonstrates the necessary knowledge, skills, and abilities for the role may also be considered.
- A minimum of 2 years of relevant experience in a clinical trial environment, having gained experience in clinical trials, clinical terminology, and medical research in a Study Coordinator or similar capacity.
- Proficiency in both French and English.
- Ability to thrive in a fast-paced environment, managing multiple tasks with short deadlines.
- Strong communication skills, particularly in high-pressure situations, with a demonstrated ability to problem-solve effectively.
- A valid Driver's License and willingness to travel as required.
- Flexibility in working hours may be necessary based on the schedule of study procedures and patient visits.
Additional Information
