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Clinical Research Coordinator
2 months ago
Key Responsibilities:
Coordinate clinical trials from initiation to closure.
Manage study protocols, amendments, and documentation.
Ensure compliance with ICH-GCP, FDA, and local regulations.
Conduct site feasibility assessments and site initiation visits.
Monitor data acquisition, quality, and reporting.
Develop and manage study budgets and contracts.
Collaborate with investigators, sponsors, and CROs.
Maintain accurate records and trial master files.
Requirements:
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field.
Minimum 5 years of experience in clinical research coordination.
Proven experience in managing domestic and international clinical trials.
In-depth knowledge of:
- ICH-GCP guidelines
- FDA regulations
- Local regulatory requirements
- GCP compliance
- Data management and reporting
Desirable Qualifications:
Certification in Clinical Research (CCRA, CCRP, etc.).
Experience with CTMS, EDC, and other research software.
Familiarity with medical writing and publishing.
Strong analytical and problem-solving skills.