Senior Clinical Research Coordinator
vor 3 Wochen
Job Summary:
PSI is seeking a highly skilled Clinical Research Associate Lead to join our team. As a key member of our clinical operations team, you will be responsible for leading the coordination of investigator/site feasibility and identification process, study startup, and project timelines.
Key Responsibilities:
- Ensure compliance with monitoring visit reports and manage Monitors in the query resolution process.
- Coordinate safety information flow and protocol/process deviation reporting.
- Manage clinical supplies with vendors and oversee site contracting and payments.
- Act as the main communication line between project team members and stakeholders.
- Conduct site audit preparation visits and oversee CAPA development and implementation.
- Provide project-specific training and deliver trainings and presentations at Investigator Meetings.
- Supervise site selection, initiation, routine monitoring, and closeout visits.
- Ensure data integrity, compliance, and proper handling of Investigational Product(s) and clinical study supplies.
Requirements:
- Relevant educational background in Life Sciences.
- Minimum 5 years' site monitoring experience in global clinical projects.
- Strong experience in Oncology preferred.
- Proficiency in English and MS Office applications.
- Ability to plan, multitask, and work in a dynamic team environment.
- Excellent communication, collaboration, and problem-solving skills.
- Ability to travel up to 65%.
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