Nurse Practitioner

ELEVATE CLINICAL RESEARCH, INC.•Big Sioux Township, SD

13d

About The Position

We are seeking a Nurse Practitioner (NP) to join our clinical research site team. In this role, you will support the Principal Investigator's medical oversight of study participants and may also provide backup support to Clinical Research Coordinators (CRCs) as needed to help keep studies running smoothly. Specific scope of responsibility (including any delegated investigator-level duties) will be defined per protocol and per the site's delegation of authority log. This position suits an NP who wants hands-on exposure to both the clinical and operational sides of running clinical trials at a research site.

Requirements

Master's or Doctoral degree in Nursing from an accredited Nurse Practitioner program
Current, unrestricted NP license in South Dakota; national certification (e.g., ANCC, AANP)
Active DEA registration (or eligibility to obtain)
1–3 years of clinical experience as an NP
Strong assessment, documentation, and communication skills
Ability to work collaboratively within a multidisciplinary research team

Nice To Haves

Prior experience in clinical trials, either in a clinical or coordinator-facing capacity, or a research-intensive clinical setting
Familiarity with delegation-of-authority logs, GCP, IRB processes, and FDA regulatory requirements
CCRP, CCRC, or similar clinical research certification (or willingness to obtain)
Comfort working across both clinical and administrative/operational tasks as the site's needs require
Experience with electronic data capture (EDC) systems and electronic health records (EHR)

Responsibilities

Perform study visits, including history and physical exams, symptom assessments, and protocol-required evaluations, per delegation of authority
Support clinical eligibility determinations for screening and enrollment
Identify, assess, document, and report adverse events (AEs) and serious adverse events (SAEs) within regulatory timelines
Order, review, and act on laboratory results, diagnostics, and other protocol-specified assessments
Administer or oversee administration of investigational product per protocol
Sign off on source documents and regulatory paperwork where delegated
Represent the site during sponsor visits, monitoring visits, audits, or inspections as designated
Assist with participant scheduling, visit logistics, and protocol calendars, particularly to help cover gaps in coordinator availability
Support data entry into EDC systems and resolution of sponsor/monitor queries
Assist with informed consent process, participant education, and retention efforts
Help maintain drug/device accountability logs and regulatory binders
Maintain accurate and complete source documentation and case report forms (CRFs)
Ensure all activities comply with FDA regulations, ICH-GCP guidelines, IRB requirements, and institutional SOPs
Collaborate closely with the PI, other clinical staff, CRCs, and sponsor/CRO representatives
Support protocol feasibility review and study start-up activities as needed