Overnight Registered Nurse (RN) – Phase 1 Clinical Research Position Summary
The Overnight Registered Nurse (RN) is responsible for providing safe, compassionate, and protocol-compliant nursing care to study participants during overnight Phase 1 clinical research studies. The RN works closely with the Principal Investigator, Sub-Investigators, Clinical Research Coordinators, PCTs, and other members of the research team to ensure participant safety and the accurate execution of study-specific procedures.
The Overnight RN plays a critical role in monitoring participants throughout extended and overnight study stays, identifying and escalating changes in participant condition, completing protocol-required assessments within specified time windows, administering medications as delegated and authorized, and maintaining accurate clinical and research documentation.
Essential Duties and Responsibilities
- Provide professional nursing care and continuous participant monitoring during overnight Phase 1 clinical research studies.
- Monitor participants for changes in condition, adverse events (AEs), treatment-emergent symptoms, and other safety concerns.
- Obtain and document protocol-required vital signs, including blood pressure, heart rate, respiratory rate, temperature, and oxygen saturation.
- Perform and document orthostatic vital signs and other clinical assessments as required by study protocol.
- Perform ECGs and other study-related assessments as trained and delegated.
- Administer investigational product, concomitant medications, and other medications as permitted by licensure, delegation, and study protocol.
- Follow all protocol-specific dosing, observation, monitoring, and safety requirements.
- Complete time-sensitive study procedures within required protocol windows.
- Monitor participants following investigational product administration and promptly communicate any concerning findings to the Investigator or designated medical staff.
- Assess, document, and appropriately escalate participant complaints, symptoms, abnormal findings, and potential adverse events.
- Respond appropriately to medical emergencies and activate emergency procedures when necessary.
- Assist with participant transfers, ambulation, and restroom needs when clinically appropriate and within scope of practice.
- Maintain participant privacy, dignity, comfort, and confidentiality throughout the study stay.
- Perform blood and urine specimen collection and other specimen-related procedures as trained and delegated.
- Ensure specimens are collected, labeled, processed, stored, and documented according to protocol and site procedures.
- Maintain accurate source documentation for all nursing assessments, interventions, observations, medications, vital signs, and participant complaints.
- Document adverse events and other clinically significant findings promptly and accurately.
- Communicate all relevant participant updates and safety concerns to the Investigator and research team.
- Conduct appropriate handoff communication to incoming clinical staff at the completion of the overnight shift.
- Review study-specific instructions and overnight schedules prior to beginning participant monitoring.
- Maintain awareness of protocol-specific timing requirements, including dosing, vital signs, ECGs, laboratory collections, and other assessments.
- Assist with maintaining a safe, clean, and organized clinical environment.
- Follow site SOPs, study protocols, GCP requirements, infection-control procedures, HIPAA requirements, and applicable regulatory requirements.
- Maintain all required nursing licenses, certifications, training, and study-specific competencies.
- Participate in study-specific training and staff meetings as required.
- Perform other clinical and research-related duties as assigned.
Phase 1 Clinical Research Responsibilities
- Provide nursing coverage for inpatient and extended-stay Phase 1 studies, including overnight and weekend coverage when required.
- Closely monitor participants following investigational product administration according to protocol-specific requirements.
- Perform frequent and scheduled safety assessments according to protocol.
- Maintain strict adherence to protocol-required time points and observation periods.
- Identify and immediately report abnormal vital signs, ECG findings, symptoms, changes in mental status, falls, injuries, or other potential safety concerns.
- Ensure all clinical observations and interventions are documented contemporaneously and accurately.
- Support the research team in maintaining participant safety while ensuring protocol compliance.
- Assist with unplanned clinical assessments when participants report new symptoms or changes in condition.
- Maintain accurate accountability and documentation related to medications administered during the shift.
- Ensure all overnight study activities are completed and appropriately communicated during shift handoff.
Participant Care
- Provide a professional and reassuring presence for participants during overnight study stays.
- Assist participants with comfort needs, positioning, ambulation, and restroom assistance as needed.
- Maintain participant privacy and dignity during all care activities.
- Monitor participants who are resting or sleeping and perform required assessments without compromising participant safety.
- Recognize when a participant requires additional clinical evaluation and promptly notify the appropriate medical personnel.
Documentation and Compliance
- Complete all nursing and study-related documentation accurately and within required timelines.
- Maintain accurate source documentation and electronic clinical records.
- Document vital signs, assessments, medications, interventions, participant complaints, and communications with the Investigator.
- Ensure documentation is consistent with protocol requirements, site SOPs, GCP, and applicable regulations.
- Promptly identify and report potential protocol deviations or missed study procedures.
Qualifications
- Current, unrestricted Registered Nurse (RN) license in the applicable state.
- Associate's or Bachelor's degree in Nursing from an accredited nursing program.
- Current BLS certification required.
- ACLS certification preferred and may be required for applicable studies.
- Previous clinical research experience preferred.
- Previous Phase 1, inpatient, emergency department, critical care, telemetry, or other acute-care nursing experience preferred.
- Phlebotomy and ECG experience preferred.
- Experience with medication administration and clinical assessment required.
Skills and Competencies
- Strong clinical assessment and critical-thinking skills.
- Excellent attention to detail.
- Ability to recognize subtle changes in participant condition and escalate appropriately.
- Ability to follow detailed study protocols and time-sensitive procedures.
- Strong documentation and communication skills.
- Ability to work independently during overnight hours while maintaining appropriate communication with the Investigator and research team.
- Ability to remain alert and attentive throughout overnight shifts.
- Strong understanding of patient safety, infection control, and emergency procedures.
- Professional, compassionate, and participant-centered approach.
- Ability to work effectively in a fast-paced clinical research environment.
Schedule and Work Environment
This is an overnight clinical position supporting Phase 1 clinical research studies. The position may require extended shifts, overnight stays, weekends, holidays, and variable schedules based on study enrollment and protocol requirements.
The RN must be comfortable providing care and monitoring to participants for extended periods while maintaining a high level of clinical vigilance and adherence to study protocols.
Physical Requirements
- Ability to stand and walk for extended periods.
- Ability to assist participants with ambulation, transfers, and restroom needs.
- Ability to respond promptly to participant needs and medical emergencies.
- Ability to perform clinical assessments and procedures throughout an overnight shift.
- Ability to lift and move clinical equipment and supplies as required.
Pay: $60.00 per hour
License/Certification:
Ability to Commute:
- Naples, FL 34105 (Required)
Work Location: In person
