Overview : We are seeking an experienced and dedicated Research Site Manager to oversee the operations of our clinical research site.
The ideal candidate will have at least 2 years of experience in clinical research management, with a strong preference for experience in therapeutic areas such as NASH (Non-Alcoholic Steatohepatitis), Obesity, Cancer, or CNS (Central Nervous System) disorders.
Key Responsibilities :
- Oversee the day-to-day operations of the clinical research site, ensuring that all activities comply with study protocols, regulatory requirements, and Good Clinical Practice (GCP).
- Manage a team of clinical research coordinators, providing guidance, training, and support to ensure high-quality performance.
- Collaborate with investigators, sponsors, and CROs to ensure the successful execution of clinical trials from start-up to close-out.
- Monitor study progress, including participant recruitment, data collection, and regulatory compliance.
- Develop and implement site-specific processes to optimize efficiency and quality in trial management.
- Review and approve study-related documents, such as informed consent forms, case report forms, and monitoring reports.
- Ensure accurate and timely data entry, query resolution, and reporting in clinical databases.
- Manage site budgets, including the allocation of resources and financial oversight of study-related expenses.
- Foster strong relationships with study participants, staff, and external stakeholders to ensure a positive and professional environment.
- Address and resolve any issues or challenges that arise during the course of the clinical trials.
Qualifications :
- Bachelor’s degree in a related field (e.g., life sciences, nursing, psychology).
- Minimum of 2 years of experience in clinical research management, with a preference for experience in NASH, Obesity, Cancer, or CNS disorders.
- In-depth knowledge of GCP, FDA regulations, and clinical trial processes.
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