Clinical Research Coordinator - Irving, United States - Medix™

Description

Position Overview:

As a Clinical Research Coordinator, you will play a key role in the planning, implementation, and coordination of clinical research studies. Working closely with investigators, healthcare professionals, and study participants, you will ensure the successful execution of research protocols in compliance with regulatory guidelines and ethical standards.

Responsibilities:

1. Coordinate and manage all aspects of clinical research studies, including protocol development, participant recruitment, and data collection.
2. Obtain necessary regulatory approvals and maintain compliance with local, state, and federal regulations.
3. Collaborate with interdisciplinary teams, including principal investigators, physicians, nurses, and other healthcare professionals.
4. Develop and maintain study documentation, including informed consent forms, case report forms, and study manuals.
5. Monitor and report adverse events, ensuring timely and accurate documentation and reporting to regulatory authorities.
6. Conduct study participant visits, collect and manage study-related data, and ensure protocol adherence.
7. Maintain effective communication with study sponsors, vendors, and internal stakeholders.
8. Organize and participate in site initiation visits, monitoring visits, and close-out visits.
9. Provide training and support to study site staff as needed.
10. Contribute to the development and improvement of standard operating procedures (SOPs) for clinical research activities.