What are the responsibilities and job description for the Clinical Research Nurse Practitioner position at Folio Clinical Research?
Research Nurse Practitioner - Arlington, TX
About Folio Clinical Research
Folio Clinical Research is a leading urologic research network treating urologic cancers, urinary stones, Peyronie’s disease, sexual and erectile dysfunction (ED), low testosterone, prostate disorders, urinary incontinence, and more. We partner with leading physician practices to create a cohesive, quality-oriented clinical culture, facilitating best practice sharing across our platform. Our affiliated practices gain access to a broad suite of clinical trials, providing significant benefits to both physicians and patients.
Position Overview
Folio Clinical Research is seeking an experienced Nurse Practitioner (NP) with a strong urology background and clinical research experience to join our team in Arlington, TX. This role is ideal for someone who understands the clinical trial environment, is comfortable working under a protocol, and is ready to step into a Sub-Investigator (Sub-I) role from day one. Candidates who have previously served as a Principal Investigator (PI) or Sub-Investigator on industry-sponsored studies are strongly preferred.
This position works closely with the VP, Clinical Operations and Principal Investigator while playing an important role in advancing new treatments in urologic care. We are looking for someone who is committed to patient safety, data integrity, and creating a positive experience for study participants while helping move research forward.
Key Responsibilities:
- Sub-Investigator / Investigator Duties: Serve as Sub-Investigator on assigned trials; perform delegated tasks per the FDA Form 1572 and delegation log, including participant eligibility assessments, physical examinations, informed consent, investigational product administration, and adverse event evaluation.
- Clinical & Participant Care: Conduct participant screenings, perform urologic-focused physical exams, review medical histories, reconcile medications, interpret labs and diagnostics, and monitor participants for adverse events and safety signals throughout the trial.
- Regulatory and GCP Compliance: Ensure all research activities comply with ICH-GCP guidelines, FDA/IRB requirements, and sponsor protocols. Maintain accurate source documentation and case report forms (CRFs); support monitoring visits, audits, and sponsor queries.
- Stakeholder Coordination: Maintain regular and effective communication with Sponsors, Contract Research Organizations (CROs), and internal team members (e.g., Principal Investigator, Medical Director, Coordinators) to facilitate study progress and participant safety.
- Meeting Participation: Engage in Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), investigator meetings, sponsor calls, and other key study meetings as required.
- Participant Recruitment & Enrollment: Support participant identification, screening, and enrollment efforts; assist with recruitment strategies tailored to the urology patient population served by Folio’s affiliated practices.
- Inventory and Equipment Management: Oversee study-specific supplies and investigational product accountability; ensure proper storage, handling, and documentation of all study materials per protocol and sponsor requirements.
Qualifications:
- MSN or DNP from an accredited program; current, active, unrestricted APRN/NP licensure in Texas; active DEA certificate and prescriptive authority; NP national board certification; current BLS/CPR. No NPDB reports.
- Minimum 2 years of urology NP experience (Required); working knowledge of urologic conditions including BPH, bladder cancer, OAB, prostate disorders, Peyronie’s disease, ED, low testosterone, and urinary incontinence.
- Minimum 1 year of clinical research experience with demonstrated Sub-Investigator (Sub-I) experience on at least one industry-sponsored trial (Required); prior PI experience preferred.
- Working knowledge of GCP guidelines, FDA regulations, and IRB processes; ability to assess and report adverse events, complete CRFs accurately, and manage protocol deviations.
- Strong written and verbal communication skills; ability to explain complex medical and research information to diverse participants and collaborate effectively with physicians, sponsors, and CROs.
- Strong attention to detail with the ability to manage multiple concurrent trials independently; proficiency with MS Office and experience with EDC, CTMS, and/or eTMF systems; CITI training and CCRC/CCRP certification a plus.
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Folio Clinical Research is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.