Key Responsibilities:
1. Coordinate and oversee the day-to-day operations of clinical trials.
2. Assist PI in recruiting, screening, and enrolling study participants.
3. Assist PI in obtaining informed consent from study participants.
4. Schedule and conduct participant visits and follow-ups.
5. Collect and record accurate data in accordance with the study protocol.
6. Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
7. Maintain study documentation and ensure data integrity.
8. Assist in preparing EC dossier for EC submission.
9. Communicate effectively with study CRO, sponsors, investigators, EC and other stakeholders.
10 Monitor study progress and report any issues or deviations from the protocol to the study sponsor or principal investigator.
11. Participate in site visits, audits, and inspections as required.
12. Provide regular updates and reports to the clinical research team and management.
Qualifications & Experience:
1. Master's/Bachelor's degree in life sciences, healthcare, or a related field.
2. Previous experience in clinical research or a related field is preferred
3. Knowledge of GCP, ICH guidelines, and regulatory requirements.
4. Strong organizational and time-management skills.
5. Excellent communication and interpersonal skills.
6. Attention to detail and ability to maintain accurate records.
7. Proficiency in Microsoft Office and clinical trial management software.