Job Summary We are seeking an experienced, dedicated, and highly organized Clinical Research Coordinator to oversee the planning, execution, and management of industry-sponsored clinical trials. The ideal candidate will have at least one year experience coordinating multiple outpatient clinical trials with significant time spent working with protocols, study patients, sponsor/CRO representatives, and Investigators. As a key member of our research team, you will coordinate study activities, ensure adherence to regulatory guidelines, and facilitate communication among stakeholders to advance innovative healthcare solutions. The Institute's focus is on Phase 2-3 trials in metabolism, especially obesity and diabetes, as well as vaccines. This role offers an exciting opportunity to contribute to impactful medical research in a dynamic environment committed to excellence. Duties Coordinate all aspects of clinical trials, including source worksheet design, supply and IP management, informed consent processes, assessments, AE/conmed updates, scheduling and following up with subjects. Monitor patient safety and well-being throughout the study, ensuring compliance with ethical guidelines and regulatory standards such as ICH GCP and FDA regulations. Review and verify documentation for accuracy, completeness, and regulatory compliance, and transcribe source data to case report forms (CRFs). Supervise Research Assistant(s) and collaborate with other teams to ensure project milestones are met efficiently. Conduct patient assessments such as vital signs measurement, ECGs, questionnaires. Ensure adherence to healthcare compliance standards such as HIPAA and clinical ethical guidelines during all study activities. Experience Proven experience in industry-sponsored clinical research settings with comprehensive knowledge of clinical trials management processes. Familiarity with medical terminology, clinical trial protocols, and regulatory requirements including ICH GCP. Proficiency in data management tools, Microsoft Office Suite, and experience with vendor software such as electronic diaries. Knowledge of healthcare compliance standards including HIPAA regulations and clinical quality assurance standards. Strong understanding of research project management principles within a regulated environment involving clinical ethical guidelines and research compliance standards. Join our team as a Clinical Research Coordinator to advance groundbreaking health advances through meticulous research practices and unwavering commitment to excellence in patient care and scientific discovery!

Pay:

$65,000.00 - $100,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Retirement plan Application Question(s): Are you currently residing in the State of Hawai'i?

Experience:

Clinical Research:

1 year (Preferred)

Work Location:

In person