Atrium Health Vaccine/Research APP - Charlotte, NC
Charlotte, NC, United States
Job ID: 99670
Job Family: Advanced Practice Provider
Specialty: Pediatrics, Specialty
Status: Full Time
Detailed Shift and Schedule: M-F, 8 am - 5 pm
Job Type: Regular
Department Name: 55541005040306-Vaccine Trials
If it’s possible, you will find it at Atrium Health—the leading community-focused academic healthcare system serving North Carolina, South Carolina and Georgia. We invite Physicians to discover all that we can do when we bring healing hearts, inquisitive minds, and progressive visionaries together.
Role: Sub-investigator for vaccine clinical trials
Hours: 40 hours per week, start with 8-5pm windows, may have evening or weekend responsibilities over time, these will be known and planned in advance. Shift will be a minimum of 4-6 hours, and could be 9-10 hours
- Review of medical history, medications and assess these against the inclusion and exclusion criteria for the study.
- Obtain informed consent in a team model, and support team as participants have questions.
- Perform physical exams, based on history and concerns and protocol requirements.
- Evaluate study diaries and discuss s/s with participants.
- Serve in a blinded or unblinded capacity on different trials, as study needs dictate.
- Will not be providing COVID-19 care, but may be obtaining swabs in research settings, may be working with COVID-19 positive patients in research context.
- Will be responsible for referring individuals who test COVID 19 positive to the Virtual Hospital or Hospital at Home AH program if the research protocol is part of initial diagnosis of COVID-19.
- Data capture, and clarification of EMR and medical history for staff making calls and reviewing registries, and enrollment and study visits.
- May make calls to registrants, to determine interest in participating in Vaccine and other trials, assess eligibility.
- Serve as informal spokesperson for research, Vaccines and COVID-19 vaccine.
- Gather information about AE’s, SAE’s and draft and submit reports, in conjunction with PI and investigator team.
- Complete Source documents, EDC, and resolution of appropriate queries in conjunction with the study team
- Review safety information for SUSARs, and sponsor reports.
- Support development and education of research team as needed for SOP’s, GCP, clinical trials protocols, study procedures.
- Participate in Research project development, grant submission activities, protocol development, and IRB submissions with investigator and research teams, and participate in academic activity such as abstract and manuscript writing and submission.
- Work with research teams and data scientists to develop skills with REDCap and other electronic data systems in support of specific research projects.
- Able to perform history, physical and study related assessments as described.
- CITI training for research, including GCP (can do this once onboard)
- Protocol training with all investigators
- Sponsor required CRF, lab, study portal training.
- Must be licensed in NC.
When you join Atrium Health, you will be welcomed into an inclusive culture that celebrates and respects the contributions a diverse team can make together. Practice where your voice is valued, your passion for advancing medicine is rewarded, and you get the resources and support you need to thrive personally and professionally. In our nationally-renowned integrated health system, you can work alongside the most advanced minds in medicine to improve medicine, elevate hope and advance healing—for all.