Senior Clinical Research Specialist
2 semanas atrás
This role is responsible for ensuring the successful execution of clinical trials. The Clinical Research Associate will monitor and manage clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations.
The ideal candidate will have a strong understanding of Good Clinical Practice (GCP) and ICH guidelines, as well as at least 1 year of on-site monitoring experience.
This is a field-based position requiring regular travel.
Key Responsibilities:- Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work.
- Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
- Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
- Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
- Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
- Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF).
- Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
- Bachelor's degree in life sciences or health-related field.
- At least 1 year of on-site monitoring experience.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements.
- Ability to travel as required by the project.
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