Purpose Perform the day-to-day administrative activities of clinical research trial programs. Provide support to the team to facilitate the achievement of the program's goals. Assist with recruiting, training, and supervising staff and managing the program budget. Primary Functions * Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate education and training for program participants. * Project/patient coordination for research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants. * Monitor study related activities on patient and protocol level. Maintain patient calendars, screening and enrollment information utilizing software tools. * Collect, analyze, and disseminate research data. Report clinical trial progress to study investigators. Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program. * Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators. Maintain program timeline including tracking deadlines for program components. * Assure compliance with all relevant IRB and other regulatory agency requirements. * Prepare IRB documents and reports. Evaluate and assist with writing of research protocols in collaboration with the study investigator. * Participate in partner related committees. Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports. * Coordinate program outreach activities including acting as a liaison with community organizations. Organize internal and external meetings, site visits, and special events. * Monitor study related budgets. Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities. |