Nurse Practitioner (NP) – Clinical Research Sub-Investigator

HR Anew•Mansfield and Lewisville, TX

7d•Onsite

About The Position

Prime Clinical Research is seeking an experienced Nurse Practitioner (NP) Sub-Investigator to support the conduct of clinical trials at our investigative site. This role works closely with the Principal Investigator and clinical research team to provide protocol-driven medical oversight, participant safety management, and high-quality clinical documentation. Clinical research experience is preferred but experienced Nurse Practitioners interested in transitioning into clinical research are encouraged to apply. The NP Sub-Investigator plays an essential role in protecting participant safety while ensuring studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. Responsibilities include participant eligibility assessments, informed consent participation, investigational product oversight, safety monitoring, and collaboration with study coordinators and sponsor teams. This position is ideal for a Nurse Practitioner who enjoys combining clinical care with medical research and contributing to the development of new therapies.

Requirements

Active Nurse Practitioner license in the practicing jurisdiction
Current national NP certification such as AANP or ANCC
Clinical experience relevant to the therapeutic areas conducted at the site or ability to onboard quickly
Knowledge of clinical trial protocols and participant safety management
Strong documentation and clinical decision-making skills
Current BLS or ACLS certification, as required by the site

Nice To Haves

Previous experience as a Sub-Investigator in clinical research
Knowledge of ICH Good Clinical Practice (GCP) and human subjects protections
Experience working with clinical research systems or Electronic Data Capture platforms
Experience participating in sponsor monitoring visits or regulatory inspections

Responsibilities

Conduct protocol-required medical evaluations including medical history review, targeted physical exams, and review of laboratory results, imaging, and ECGs
Support participant eligibility determinations and document clinical rationale for inclusion or exclusion decisions
Collaborate with the Principal Investigator on complex eligibility cases and clinical decision-making
Participate in the informed consent process and ensure participants understand study procedures, risks, and alternatives
Support re-consent following protocol amendments when required
Ensure participant rights, safety, and autonomy are maintained throughout the study
Detect, assess, and manage adverse events and serious adverse events in accordance with protocol and regulatory requirements
Initiate protocol-directed actions such as dose modifications, treatment holds, or discontinuations when necessary
Provide appropriate clinical follow-up and ensure accurate safety documentation
Ensure investigational product prescribing, dosing, and administration follow protocol requirements
Review concomitant medications for potential interactions or protocol restrictions
Recognize and manage infusion or administration reactions in collaboration with the study team
Maintain timely, accurate source documentation aligned with ALCOA+ documentation standards
Ensure clinical documentation supports Electronic Data Capture entries and regulatory requirements
Collaborate with Study Coordinators to resolve data discrepancies and ensure documentation accuracy
Participate in sponsor monitoring visits, audits, and regulatory inspections as required
Support corrective and preventive action activities when needed
Maintain inspection readiness through high-quality documentation and adherence to site SOPs
Work closely with Principal Investigators, Study Coordinators, research staff, and sponsor teams
Support training and mentoring of research staff on clinical oversight and safety processes
Promote patient-centered research practices and high standards of clinical care