What are the responsibilities and job description for the Clinical Research Site Manager - 224179 position at Medix™?
Position Summary:
As the Clinical Research Site Manager, you will oversee the day-to-day operations of clinical research trials at the site level. You will manage site staff, ensure regulatory compliance, monitor patient recruitment, and be the point of contact between the sponsor and site teams. Your expertise will be critical in maintaining high standards of patient care, data integrity, and adherence to study protocols.
Key Responsibilities:
- Oversee the implementation and day-to-day management of clinical research trials at the site level.
- Ensure that clinical trials are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Act as the primary contact between the sponsor and site, ensuring effective communication throughout the study lifecycle.
- Manage patient recruitment and retention strategies, ensuring that enrollment targets are met.
- Ensure proper informed consent processes are followed and that participant safety is prioritized.
- Maintain accurate and up-to-date documentation, including study binders, regulatory files, and source documents.
- Coordinate site meetings, study visits, and investigator meetings as needed.
- Manage study budgets, timelines, and resources to ensure efficient operations and on-time completion of studies.
- Provide guidance and training to site staff and ensure proper protocol adherence.
- Troubleshoot and resolve any study-related issues or challenges that arise during the trial.
- Review and ensure that clinical data is accurate, complete, and submitted on time.
Qualifications:
- Bachelor’s degree in Life Sciences, Nursing, or a related field (or equivalent experience).
- Minimum of 4 years of experience in clinical research, with at least 1 years in a site management or coordinator role.
- Strong knowledge of GCP, ICH guidelines, and FDA regulations.
- Proven ability to manage multiple projects and prioritize tasks in a fast-paced environment.
- Exceptional organizational and communication skills.
- Strong problem-solving abilities and attention to detail.
- Experience with clinical trial management software (CTMS) and Electronic Data Capture (EDC) systems is a plus.
