Job Summary
We are seeking a dynamic and detail-oriented Clinical Research Coordinator to join our innovative healthcare team. In this vital 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 collection of high-quality data, monitor patient safety, and support the advancement of medical research. This paid position offers an exciting opportunity to contribute to groundbreaking clinical studies that improve patient outcomes worldwide.
Responsibilities
- Coordinate all aspects of clinical trial activities, including participant recruitment, scheduling, and follow-up visits.
- Review and verify clinical documentation to ensure accuracy, completeness, and compliance with FDA regulations and ICH GCP guidelines.
- Monitor patient progress throughout trials by recording vital signs, blood samples, and other clinical data using EMR (Electronic Medical Records) systems.
- Manage data collection processes in accordance with CDISC standards and ensure proper documentation review for regulatory submissions.
- Supervise research staff and collaborate with multidisciplinary teams to maintain adherence to research protocols and healthcare compliance standards.
- Conduct patient monitoring activities such as blood sampling, phlebotomy, and assessment of clinical laboratory results.
- Ensure all research activities comply with HIPAA privacy rules, clinical ethical guidelines, and institutional policies for data management and safety.
Requirements
- Proven experience supervising clinical research projects within a healthcare or research setting.
- Strong knowledge of clinical trials management, FDA regulations, ICH GCP certification (or equivalent), and healthcare compliance standards.
- Familiarity with clinical laboratory procedures, blood sampling techniques, phlebotomy, and vital signs measurement.
- Proficiency in using EMR systems, statistical software, and data management tools for research purposes.
- Excellent understanding of medical terminology, clinical development processes, and research ethical guidelines.
- Project management experience in healthcare environments with the ability to coordinate multiple tasks efficiently.
- Valid certification in GCP from a recognized issuer for CA or equivalent certification in clinical research ethics.
- Ability to review complex documentation accurately while maintaining meticulous records for regulatory audits.
- Strong analysis skills coupled with attention to detail to support high-quality data collection and reporting.
Join us in advancing medical science through innovative research! This role offers a fulfilling career path for professionals passionate about improving health outcomes through meticulous research coordination while working within a collaborative and compliant environment.
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
