This position in the Pediatric Infectious Disease Department is responsible for managing the regulatory functions 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.
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?
* Day Shift/ Non-Exempt Position
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Follows policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research * Implement policies, procedures and regulations to identify when a patient can/cannot be enrolled on a study * Report protocol non-compliance, adverse events and serious adverse events
Implementation, coordination, management and reporting of clinical/translational research operations * Review protocols and assist in the development of source documentation to capture data time points needed to obtain objectives of the protocol. * Train internal and external research staff on protocol and trial expectations as needed.
Serves as an advocate for human subjects * Establish and maintain 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 * Work with internal and external research staff on protocol expectations and reporting guidelines * Elevate issues to PI, FDA and other governing bodies as needed to ensure human subject protection
Actively identifies and participates in training, education, and development activities * Improves own knowledge and performance to sustain and enhance professional development. * Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.) * Engages in continuous, job-related educational activities, actively seeking new learning opportunities.
Bachelor's Degree (or equivalent experience) and 2 year experience