Knoxville, TN30+ days ago
p>Key Responsibilities • Assist with the day-to-day operations of clinical research studies and trials • Support participant recruitment, screening, enrollment, and follow-up activities • Collect, record, and maintain accurate study data in case report forms (CRFs), electronic data capture systems, and source documents • Prepare and maintain regulatory binders and study documentation in accordance with IRB, GCP, and sponsor requirements • Coordinate study visits, schedules, and communications with participants and study staff • Assist with informed consent processes under the supervision of authorized personnel • Perform basic clinical tasks as permitted (e.g., vital signs, specimen handling, questionnaire administration) • Able to do lab draws on patients • Support monitoring visits, audits, and inspections • Ensure confidentiality and proper handling of protected health information (PHI) • Communicate effectively with investigators, coordinators, sponsors, and regulatory bodies • Assist with inventory management of study supplies and investigational products (as applicable). Skills and Competencies: • Strong time management and multitasking abilities • Professional and ethical conduct • Ability to work independently and as part of a multidisciplinary team • Problem-solving and critical-thinking skills • Comfort interacting with patients and research participants.