Job Summary
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this pivotal role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and ethical guidelines. Your expertise will facilitate the successful conduct of research projects that contribute to advancing healthcare solutions. This position offers an exciting opportunity to work in a collaborative environment dedicated to innovation and excellence in clinical research.
Duties
- Coordinate all aspects of clinical trials, including participant recruitment, screening, enrollment, and follow-up procedures.
- Ensure adherence to FDA regulations, ICH GCP guidelines, and institutional policies throughout the study lifecycle.
- Review and verify study documentation, including consent forms, case report forms, and regulatory submissions for accuracy and completeness.
- Monitor patient progress by tracking vital signs, blood sampling, and other clinical assessments while maintaining meticulous records.
- Manage data collection and entry using electronic medical record (EMR) systems and ensure data integrity in compliance with CDISC standards.
- Supervise research staff and collaborate with healthcare professionals to facilitate smooth trial operations.
- Conduct clinical laboratory procedures such as phlebotomy and blood sampling while maintaining safety protocols.
- Prepare reports for regulatory agencies, sponsors, and internal stakeholders; assist in audit preparations and compliance management.
Skills
- Proven supervising experience in a clinical research or healthcare setting with strong project management skills.
- Extensive knowledge of clinical trials management, including patient monitoring and data management processes.
- Proficiency in medical terminology, clinical laboratory techniques, and analysis skills related to research data.
- Familiarity with FDA regulations, ICH GCP standards, HIPAA compliance, and healthcare ethical guidelines.
- Experience with EMR systems, statistical software tools, and CDISC data standards for clinical research data analysis.
- Strong documentation review skills ensuring accuracy in research documentation and regulatory submissions.
- Ability to manage multiple projects efficiently while maintaining high-quality standards; excellent organizational skills are essential.
Join us to be part of a forward-thinking organization committed to transforming healthcare through innovative research! We value energetic professionals who thrive in collaborative environments and are passionate about making a difference in patient care through rigorous scientific inquiry. All roles are paid positions that support your professional growth within the vibrant field of clinical research.
Pay: $32.00 - $36.00 per hour
Work Location: In person