Senior Clinical Research Coordinator

Senior Clinical Research Coordinator Dream Sleep Medicine Frisco, TX Job Details Full-time $53,835.52 - $84,834.17 a year 13 hours ago Qualifications Managing scientific research projects Statistical software Statistics Patient progress tracking Teamwork Electronic health records (EHR) management HIPAA Phlebotomy specimen handling Patient safety ICH guidelines Supervising experience Research safety & compliance Team management Attention to detail Data quality monitoring Healthcare privacy protection Medical laboratory work Managing clinical research teams Health information regulatory compliance Organizational skills Healthcare team management Implementing research protocols Patient progress monitoring Clinical quality assurance standards Managing patient records Clinical data analysis Medical terminology Documentation review FDA regulations Documentation reviews Full Job Description Job Summary We are seeking a highly motivated and detail-oriented Senior Clinical Research Coordinator to join our dynamic research team. In this pivotal role, you will oversee the planning, execution, and management of complex clinical trials, ensuring compliance with regulatory standards and maintaining the highest quality of data collection. Your expertise will drive the success of our clinical development programs, contributing to groundbreaking medical advancements. This position offers an exciting opportunity to lead research initiatives, supervise team members, and collaborate across multidisciplinary teams to advance healthcare solutions. Responsibilities Lead and supervise clinical research staff, providing guidance on study protocols, regulatory compliance, and data management practices. Coordinate all aspects of clinical trials, including patient recruitment, screening, enrollment, and ongoing monitoring. Review and ensure accuracy of study documentation, including consent forms, case report forms, and regulatory submissions. Monitor patient safety by conducting vital signs assessments, blood sampling (phlebotomy), and tracking adverse events in accordance with protocol guidelines. Manage data collection processes using electronic medical record (EMR) systems and ensure adherence to CDISC standards for data formatting. Maintain compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other applicable legal requirements. Collaborate with clinical laboratories for specimen handling and analysis; utilize statistical software for data analysis when necessary. Conduct regular site audits to ensure protocol adherence and prepare documentation for regulatory inspections. Requirements Proven supervising experience in a clinical research setting or related healthcare environment. Extensive knowledge of clinical trials management processes and regulatory frameworks such as FDA regulations and ICH GCP standards. Strong understanding of medical terminology, clinical laboratory procedures, blood sampling techniques, and vital signs measurement. Experience reviewing study documentation for accuracy and completeness; familiarity with EMR systems is essential. Ability to monitor patient progress effectively while ensuring compliance with study protocols and safety guidelines. Proficiency in statistical software tools used for data analysis; familiarity with CDISC standards is a plus. Certification in Good Clinical Practice (GCP) from a recognized issuer; valid ICH GCP certificate preferred. Background in nursing or clinical laboratory work is advantageous; knowledge of HIPAA regulations is required. Excellent analysis skills combined with strong organizational abilities to manage multiple studies simultaneously while maintaining meticulous documentation. Join us in advancing innovative healthcare solutions through dedicated research efforts! We are committed to fostering a collaborative environment where your expertise makes a meaningful impact on patient outcomes worldwide.

Pay:

$53,835.52 - $84,834.17 per year

Work Location:

In person