Clinical Study Associate Manager
Vor 7 Tagen
We are a clinical-stage health-tech start-up company with a mission to revolutionize cancer diagnosis and treatment optimization using our innovative nanomechanical biomarker.
Job OverviewThe Clinical Research Associate (CRA) plays a crucial role in managing clinical studies for our medical products. This position requires strong expertise in regulatory compliance, study oversight, and site management.
Key Responsibilities:
- Study Design and Planning: Collaborate with cross-functional teams to design, plan, and implement clinical studies, ensuring alignment with regulatory requirements.
- Regulatory Submissions: Prepare and submit regulatory documents, including study protocols, informed consent forms, and ethics committee applications.
- Site Initiation and Monitoring: Conduct site visits to ensure compliance with study protocols and regulatory standards, providing ongoing support to site staff and investigators.
- Data Management: Oversee data entry, query resolution, and data review, ensuring accuracy and completeness of trial master files.
- Audit and Inspection Readiness: Maintain accurate and complete documentation of trial master files, conducting regular audits and site visits to ensure readiness for regulatory inspections.
- Bachelor's degree in a scientific discipline (or equivalent combination of education and experience)
- Strong knowledge of regulatory guidelines, GCP standards for medical devices, and familiarity with clinical/health systems
- Excellent communication and teamwork skills, with ability to interact professionally at all levels
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