Principal Clinical Research Associate
vor 4 Wochen
Position Overview:
- Oversee the management of investigator/site feasibility assessments and the identification process, ensuring timely study initiation and adherence to project schedules.
- Guarantee compliance with monitoring visit documentation and facilitate the query resolution process with Monitors.
- Coordinate the flow of safety information and manage reporting of protocol deviations and process discrepancies.
- Administer clinical supplies in collaboration with vendors and supervise site contracts and financial transactions.
- Serve as the primary communication conduit among project team members and stakeholders.
- Conduct preparatory visits for site audits and oversee the development and execution of Corrective and Preventive Actions (CAPA).
- Deliver project-specific training and conduct presentations at Investigator Meetings.
- Supervise the processes of site selection, initiation, routine monitoring, and study closeout visits.
- Ensure the integrity of data, compliance with regulations, and appropriate management of Investigational Products and clinical study materials.
Qualifications:
- Educational background in Life Sciences or a related field.
- A minimum of 5 years of experience in site monitoring for global clinical trials.
- Preferred expertise in Oncology.
- Proficient in English and skilled in MS Office applications.
- Strong organizational skills with the ability to multitask and thrive in a dynamic team setting.
- Exceptional communication, collaboration, and problem-solving abilities.
- Willingness to travel up to 65% of the time.
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