The Clinical Research Nurse Practitioner (APRN) & Investigator serves as a key clinical and operational leader responsible for overseeing research activities, providing direct patient care, and supporting the successful growth of IPTB Clinical Research's newest trials site. This position combines advanced clinical practice with research leadership, offering a unique opportunity to contribute to Phase II-IV pharmaceutical trials, while delivering high-quality patient care through the site's Transitional Care Clinic.
About IPTB Clinical Research
IPTB Clinical Research is a rapidly growing clinical research company dedicated to advancing healthcare through innovative clinical trials, exceptional patient care, and scientific excellence. Through strategic partnerships with pharmaceutical, biotechnology, medical device, and emerging therapeutics sponsors, IPTB conducts high-quality Phase II-IV clinical trials across multiple therapeutic areas.As part of our continued expansion, IPTB Clinical Research has launched a new research site designed to support traditional pharmaceutical studies, medical device investigations, and emerging psychedelic-assisted therapy research. The site will also integrate a Transitional Care Clinic, creating a unique model that combines clinical research, behavioral health innovation, and patient-centered healthcare services.This is an exceptional opportunity for an experienced Nurse Practitioner seeking a leadership role at the intersection of clinical practice, biomedical research, and operational leadership.
Position Summary
The Nurse Practitioner will serve as an Investigator on Phase II-IV clinical trials while providing clinical and operational leadership for research activities and patient care services. The successful candidate will work closely with Principal Investigators, site leadership, internal recruitment teams, sponsors, CROs, and research staff to ensure the highest standards of patient safety, protocol compliance, and study execution.In addition to research responsibilities, the Nurse Practitioner will provide direct patient care within the Transitional Care Clinic under physician supervision and in accordance with Florida statutes governing Advanced Practice Registered Nurses.This person will play a key leadership role in establishing operational excellence at a newly opened clinical research site and overseeing a multidisciplinary team including psychometricians, patient recruiters, clinical research coordinators, and clinical support personnel.
Primary Responsibilities
Clinical Research Leadership Investigator Duties
- Serve as a delegated Investigator on Phase II-IV pharmaceutical, device, and psychedelic clinical trials.
- Conduct protocol-required physical examinations, medical assessments, and study evaluations.
- Review participant eligibility according to study inclusion and exclusion criteria.
- Evaluate adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
- Ensure participant safety and protocol compliance throughout study participation.
- Perform clinical review and sign delegated source documentation.
- Participate in site initiation visits, sponsor monitoring visits, audits, and regulatory inspections.
- Collaborate with sponsors, CROs, Medical Directors, Principal Investigators, and study teams.
- Support study startup activities, feasibility assessments, and implementation of new protocols.
- Maintain compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional policies.
Clinical Research Operations Oversight
- Provide leadership and oversight of daily research operations.
- Supervise and mentor Clinical Research Coordinators (CRCs), research assistants, and research support personnel.
- Ensure quality control of source documentation, protocol execution, data collection, and participant management.
- Develop and implement operational workflows, standard operating procedures, and quality improvement initiatives.
- Support recruitment, retention, and engagement strategies for clinical trial participants.
- Assist in staff training and competency development.
- Promote a culture of scientific excellence, patient-centered care, compliance, and accountability.
- Support business growth initiatives and expansion of research programs.
Transitional Care Clinic Responsibilities
- Provide direct patient care services within the Transitional Care Clinic.
- Conduct comprehensive patient evaluations and physical examinations.
- Diagnose and manage acute and chronic medical conditions within scope of practice.
- Develop individualized treatment plans and coordinate follow-up care.
- Prescribe medications and therapeutic interventions as permitted by Florida regulations.
- Order, review, and interpret laboratory, diagnostic, and imaging studies.
- Coordinate care among specialists, hospitals, rehabilitation facilities, and community resources.
- Promote continuity of care and assess for eligibility in ongoing research studies.
Qualifications
Required Education, Licensure & Regulatory Requirements
- Current, unrestricted Florida Advanced Practice Registered Nurse (APRN) license in good standing. Psychiatric APRNs are encouraged to apply.
- Current Florida Registered Nurse (RN) license in good standing.
- Master's Degree, Post-Master's Certificate, or Doctor of Nursing Practice (DNP) from an accredited Nurse Practitioner program.
- Current national board certification appropriate to specialty practice.
- Current DEA registration and Florida prescribing authority, if applicable.
- Current Basic Life Support (BLS) certification.
- Ability to practice under physician supervision and protocol agreements consistent with Florida law and organizational requirements.
- Compliance with all Florida Board of Nursing continuing education and licensure requirements.
Clinical Experience
- Minimum three (3) years of Nurse Practitioner clinical experience.
- Demonstrated expertise in patient assessment, diagnosis, treatment planning, and care coordination.
- Experience in psychiatry, neurology, and/or behavioral health strongly preferred.
- Strong interpersonal, organizational, and leadership skills.
Clinical Research Qualifications
- Previous clinical research experience strongly preferred.
- Prior experience as a Sub-Investigator preferred.
- Knowledge of FDA regulations, ICH-GCP guidelines, and human subject protection requirements.
- Current Good Clinical Practice (GCP) certification or willingness to obtain certification upon hire.
- Experience with Phase II-IV clinical trials preferred.
- Familiarity with informed consent, source documentation, adverse event reporting, and protocol compliance.
- Experience interacting with sponsors, CROs, monitors, auditors, and regulatory agencies preferred.
- Understanding of research quality systems, participant safety oversight, and data integrity standards.
Leadership Qualifications
- Previous experience supervising clinical or research personnel preferred.
- Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.
- Experience developing workflows, operational processes, and quality improvement initiatives.
- Ability to build collaborative relationships across multidisciplinary teams.
Why Join IPTB Clinical Research?
This position offers a rare opportunity to help build a next-generation clinical research site while maintaining meaningful patient care responsibilities. The successful candidate will work alongside leading investigators, innovative sponsors, and multidisciplinary healthcare professionals while helping shape the future of neuropsychiatric healthcare.At IPTB Clinical Research, every study represents an opportunity to improve lives, advance science, and bring innovative treatments to patients who need them most.
IPTB Clinical Research is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace.
Work Location: In person
