Jace Culley

Clinical Research Coordinator with 3 years of experience managing phase II and III clinical trials across diverse therapeutic areas, including rheumatology, endocrinology, infectious disease, and gastroenterology. Committed to advancing patient care and medical knowledge through high-quality research, with a strong focus on data accuracy, regulatory compliance, and process optimization. A lifelong learner and technology enthusiast, adept at solving complex problems and enhancing team collaboration.

• Managed the day-to-day clinical trial operations for phase III studies in rheumatology, endocrinology, gastroenterology, and infectious disease,  including recruiting, consenting, enrolling, and retaining study subjects.
• Collaborated with investigators to ensure adherence to protocol requirements, GCP, and FDA guidelines.
• Prepared and submitted regulatory documents, ensuring compliance with sponsor, IRB, and FDA requirements.
• Maintained inventory and accountability for investigational products and study supplies.
• Oversaw long-term storage and organization of study documents, ensuring audit readiness.
• Monitored and calibrated temperature data loggers, promptly reporting temperature excursions to maintain IP integrity.
• Spearheaded the transition from paper-based processes to electronic alternatives, improving efficiency and turnaround.
• Trained and mentored fellow coordinators on SOPs, regulatory submissions, and safety monitoring.
• Collected, processed, and shipped biological samples per lab manual instructions.

• I hold a Bachelor's of Science degree in Biology with a minor in chemistry/biochemistry from Eastern Washington University where I graduated summa cum laude with a 3.91 overall GPA.
• I maintain an active Medical Assistant Phlebotomist license.
• I maintain a current GCP ICH E6(R3) certificate, IATA certification and BLS CPR certificate.