We’re looking for a highly skilled Clinical Research Coordinator with a strong background in managing clinical trials. The ideal candidate will have 5+ years of experience in domestic and international trials, ensuring compliance with statutory guidelines and regulations.
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.
