Responsible for coordinating research activities related to the Florida Cohort under the supervision of the Principal Investigator of the research team. This includes the development and implementation of research team procedures, and assignment of duties to staff and students that supports the overall mission of the research team. The research coordinator should become familiar with all details of the study procedures for this project in order to oversee and teach others. We expect that the coordinator will manage and oversee 3 part-time staff locally, and communicate with 2-3 other research coordinators at sites in Tampa, Sanford, and Gainesville.
Responsible for assisting in the interpretation and implementation of federal, state, and University of Florida policies and procedures as they apply to the clinical research activities.
Communicate with all research assistants involved with the project (at least 3 statewide) regarding day-to-day issues that arise during the study project.
Plan, schedule, and coordinate research team calls and meetings that are needed to facilitate communication about and coordination of research activities.
Assist and support the principal investigator in written and oral communications with granting agencies, faculty, staff, and community groups.
Oversee procurement and maintenance of equipment and supplies (e.g. surveys) that are needed to conduct research.
Request, deliver, and monitor research subject payments using a UF gift card system.
Perform additional related duties as required or deemed appropriate to the accomplishment of the responsibilities and functions of his/her area.
Approve hours for some research staff.
Ensure that all research staff are trained in all study procedures, including new study procedures that emerge during the study.
Assist with IRB activities. Under the supervision of the PI, prepare and submit filings of new protocols, revisions, continuing reviews, study closures, and other periodic reports to Investigational Review Boards (IRB) and other regulatory agencies such as clinicaltrials.gov, NIH, University of Florida, the Florida Department of Health and other participating institutions and/or organizations.
Oversee maintenance and updates of regulatory binders and Manual of Operations at each participating clinical setting (including Tampa, Sanford, and Miami). Maintain knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding conduct of clinical trials and other clinical research activities involving human subjects.
Monitor for and document any study adverse events or research protocol deviations.
Keep current with knowledge and expertise related to IRB, and good clinical practices by attending relevant training courses, taking on-line skills training, and learning from others with similar skills.
Assist with recruitment if needed, administering informed consent and data collection from cohort participants. May need to recruit at clinical settings 1 day per week. Help to track and follow-up with participants via telephone calls, email, or other methods.
Assist in the preparation of papers, posters and manuscripts for possible publications and presentations.
Assist with creation of reports related to the data collection, etc.
Facilitate collaboration with new investigators and students from a variety of disciplines.
Help create effective promotional materials for the project.
Assist with collection of information from participant medical records, which may include the request for medical records.
Facilitate contact of participants who may be eligible for other research studies involved with our team, and who have agreed to participate in a Florida Cohort participant registry.
Creation of recruitment or follow-up packets and distribute them to recruitment team.
Collaboration with study Data Manager to help ensure appropriate and complete data entry and storage of data collection forms and surveys.
Connecting the Florida Cohort project with other research, educational, and community-based activities of the SHARC Center for Translational HIV Research (www.sharc-research.org)
Attend weekly Center team meeting, occasional SHARC Research Seminar Series, and at least one community-engagement activity per semester.
Help to oversee and teach interns, medical students, and visiting students to help with the overall Florida Cohort project.