About this opportunity
NRx Pharmaceuticals, Inc. lists this Clinical Research Nurse opportunity in sarasota, Florida. Review the employer’s description below for duties, qualifications and application requirements.
Job description
This position sits with NRx Defense Systems and is performed on-site at HOPE Therapeutics in Sarasota, Florida. HOPE Therapeutics is a clinical subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP) and operates an interventional psychiatry clinical network across Florida. We're launching a pivotal Phase III depression trial and hiring an experienced RN to lead study operations at this site. The role starts part-time and is planned to grow to full-time as enrollment ramps up.
The role
You’ll be the face and voice of the site: the main contact for patients, sponsors, CROs and monitors. You'll work under the direct oversight of the Principal Investigator. She will delegate clinical tasks to you, so she needs to be able to rely on your clinical judgment and your documentation. Success means three things: patients are enrolled on target, participants stay in the study and are managed safely, and the site is ready for an FDA inspection at all times.
What you'll do
Review medical records to find, pre-screen and enroll eligible patients against sponsor targets
Assess eligibility, obtain informed consent and manage participants through every study visit
Carry out clinical tasks the PI delegates to you, including phlebotomy, specimen processing and shipping to labs, and study procedures as trained
Keep patients in the study with reminder calls, visit-prep instructions and ongoing follow-up
Identify and report AEs and SAEs within protocol timelines
Keep EDC data, TMF/ISF and source documents current and ready for inspection
Help the PI keep the site compliant with ICH-GCP, including the delegation log, IRB submissions, deviations and IP accountability
Lead the site through monitoring visits, audits and FDA inspections, including CAPA responses
What you bring
Active RN license eligible to practice in Florida (Florida license or eNLC multistate)
Experience as Lead or Primary Study Coordinator on pharma-sponsored trials
5+ years of hands-on patient evaluation and management
Experience caring for mental health patients
Phlebotomy skills and experience handling specimens
Working knowledge of ICH-GCP, 21 CFR, EDC and TMF systems
Strongly preferred
Trial experience in MDD, TRD, suicidal ideation and behavior, or bipolar depression
Experience with MADRS, HAM-D or C-SSRS, or rater certification
TMS, ketamine or esketamine experience (TMS training is a plus)
Phase III or registrational trial experience, including FDA inspections
CCRC or ACRP-CP certification
$42–52/hour, depending on experience and certification. Medical, dental, vision, 401(k), PTO, and support for licensure and research certification.
NRx Defense Systems, HOPE Therapeutics and NRx Pharmaceuticals are equal opportunity employers.
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Worksite address
sarasota, FL, 34243, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.