Clinical Research Specialist
1 semana atrás
Job Opportunity:
We are seeking a skilled Clinical Research Professional to support the successful execution of clinical studies.
Responsibilities:
- Monitor clinical investigative sites to ensure protocol execution and adherence to regulations, good clinical practices, and quality standards.
- Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies.
- Oversee site personnel and motivate them to meet study objectives, ensuring compliance and regulatory inspection readiness.
- Ensure data quality and timely submission, including safety event reporting and follow-up.
- Train study site personnel on protocols and regulatory requirements.
- Manage investigator payments and negotiate agreements with stakeholders.
- Identify and recommend new investigators/sites for ongoing studies.
Qualifications:
- Appropriate tertiary qualification (e.g. medical, scientific, nursing) preferred.
- Minimum 1 year of clinically-related experience, with 6 months in clinical research monitoring.
- Current knowledge of therapeutic indications, ICH/GCP guidelines, and applicable regulations.
- Strong planning, organizational, analytical, and communication skills.
- Demonstrated business ethics and integrity.
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