Clin/Tran Research Coord I/Pediatric Infectious Disease
Job Summary With guidance and training, is responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. Manages screening, implements recruitment procedures, consenting, enrollment, randomization and study conduct from planning through study closeout. Performs or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities.
The division of pediatric infectious diseases features nationally and internationally-recognized leaders in vaccine development and vaccine safety, bacterial infections such as pertussis and staphylococcus aureus, viral infections such as influenza and coronaviruses (e.g. SARS), pediatric HIV/AIDS, global health, antimicrobial stewardship, and the care of children with compromised immune systems.
Why Choose Infectious Diseases Care at Children's Hospital?
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Responsibilities: 1. With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations.
2. Perform study procedures such as assessing participant eligibility and recruitment, assuring participants fulfill eligibility requirements, arranging necessary schedules and procedures, completing required participant registration in Estar, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures
3. Procures equipment and supplies needed to fulfill project requirements
4. Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
5. Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
6. Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to continue education (i.e., in-services, seminars, etc.)
Bachelor's Degree (or equivalent experience) and < 1 year experience
Additional Qualification Information: Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp