The Clinical Studies Coordinator will be an integral part of the Clinical Core Facility and will work closely with a variety of research teams to facilitate the recruitment, screening and enrollment of volunteers to participate in research studies at the La Jolla Institute for Allergy & Immunology (LJI). Duties include but are not limited to: recruiting subjects; screening for eligibility; monitoring and timely reporting of adverse events; protocol deviations; scheduling subjects’ visits; coordinating clinical, laboratory and data activities; assisting with writing and monitoring IRB protocols; collecting and entering research data; maintaining accurate and complete clinical research files.
Salary commensurate with qualifications and experience. Senior title possible based on prior experience.
Essential Duties & Responsibilities
The Clinical Coordinator will be responsible for the following duties: (100%)
• Work closely with Scientific Research and Clinical Staff to develop and independently conduct volunteer recruitment for a variety of research studies.
• Exceptional interpersonal, communication and organizational skills to perform volunteer recruitment in person, in writing, and on the telephone.
• Maintain clear and secure records to ensure protection of volunteer confidentiality, allow scheduling of screening and/or phlebotomy appointments for qualified volunteers, and assess progress of volunteer recruitment against research objectives.
• Participate in research team meetings and assist with preparation of donor enrollment summaries and/or presentations as required.
• Organize and attend weekly Clinical Committee meetings and recording meeting minutes and agendas.
• Assist Principal Investigator in writing and submitting human subject IRB protocols, amendments, and annual Status Reports for active studies.
• Create advertisements and marketing plans unique to each project.
• Be hard working, organized and flexible to ensure effective donor recruitment, enrollment, and delivery of collected research samples to scientific staff.
• Work closely with the LJI administrative team to schedule (or if certified, perform) blood draws in accordance to research study and IRB approvals.
• Organize and schedule requests for blood donors.
• Obtain and record accurate information and details to ensure proper completion of forms and reports.
• Ensure study compliance with protocols, SOP’s, and established company policies.
• Coordinate with donor pool for availability and track donors’ eligibility.
• Process payments to donors and chargebacks to labs.
• Develop study documents and tools to set up infrastructure of Core Facility (tracking forms, donor databases, communication systems, etc).
• Interface with external vendors/companies to arrange for offsite donation / sampling logistics.
• Marketing and communicating LJI Clinical Studies brand to build donor database for future study recruitment needs.
• Develop and maintain collaborative ties with local and regional institutes, clinics, and any facilities related to active research projects.
• Arrange the delivery of samples to requested labs for clinical draws that are not performed by LJI Phlebotomist.