Role Overview:
This position involves site management and monitoring responsibilities for clinical studies, ensuring adherence to SOPs, ICH GCP guidelines, and regulatory requirements. Key duties include conducting pre-study, initiation, routine, and close-out visits, verifying informed consent and protocol compliance, safeguarding data integrity through source document review, and managing regulatory documents and investigational product inventory. The role may act as a Lead CRA and requires efficient site monitoring, data verification, and collaboration with study teams to meet study deliverables. Additional responsibilities include training site staff, preparing monitoring plans, and ensuring audit readiness.
Qualifications & Skills:
- University or college degree, or related health profession certification, or equivalent experience.
- Thorough knowledge of ICH GCP guidelines, monitoring procedures, and clinical trial processes.
- Fluent in local language and English, with experience in clinical monitoring (minimum 1.5 years for external, 1 year for internal candidates).
- Ability to work independently, manage study site activities, and handle SAE reporting.
- Strong organizational, problem-solving, communication, and computer skills.
Preferred Qualifications:
- Experience with Phase I trials, additional years in related fields, or certifications.
- Knowledge of SOPs, clinical systems, and regulatory standards like ISO 14155.
- Strong interpersonal skills, attention to detail, and a methodical work approach.
Work Environment & Demands:
- Ability to sit for long periods, handle computer tasks, and travel up to 60% for site visits.
- Work may involve outside hours and in clinical or hospital environments.
- Requires good communication, confidentiality, and the ability to work effectively in a team.