Senior Trial Manager
2 weeks ago
The role of a Senior Clinical Research Coordinator is to oversee the daily operations of clinical trials at our site. This involves coordinating and managing various activities, ensuring compliance with study protocols, ICH-GCP, and applicable regulatory requirements.
Key Responsibilities:- Coordinate day-to-day clinical trial activities at the site.
- Ensure compliance with study protocols, ICH-GCP, and applicable regulatory requirements.
- Manage subject recruitment, informed consent process, screening, enrollment, and follow-up visits.
- Collect and enter accurate source data and case report forms (CRFs) in a timely manner.
- Act as a primary liaison between the site, sponsors, and monitors.
- Prepare for and support monitoring visits, audits, and regulatory inspections.
- Maintain and organize study documentation (ISF, logs, accountability records, etc.).
- Train and mentor junior coordinators as needed.
Requirements and Qualifications:
- Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
- Minimum of 1.5 years of experience coordinating clinical trials.
- Strong knowledge of ICH-GCP, Indian regulatory requirements, and ethical guidelines.
- Excellent organizational and communication skills.
- Proficient in Microsoft Office and electronic data capture (EDC) systems.
- Ability to work independently and handle multiple tasks efficiently.
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