Urology Associates, P.C. is seeking a Clinical Research Nurse for a hybrid role that splits time between two connected teams: our Clinical Research Department and our Advanced Therapeutics Center (ATC).
You will provide direct clinical care to research participants with a focus on infusion-based and procedural studies, and also provide hands-on nursing care to ATC patients receiving non-chemotherapy infusion therapy and LHRH injections.
You will work closely with Clinical Research Coordinators, the Study Start-Up team, the Regulatory team, and ATC providers and staff. You will also serve as the ATC RN’s backup when they are out of office. This role does not supervise other staff and reports to the Clinical Research Department Manager.
ABOUT THE ADVANCED THERAPEUTICS CENTER (ATC)
The ATC delivers advanced, cutting-edge therapies that complement the care patients already receive from their urology care team. It treats patients with advanced prostate and bladder cancer, including bladder instillations, immunotherapies, and androgen deprivation therapy, and helps monitor and manage treatment side effects to protect patients’ quality of life. The ATC is located at 2801 Charlotte Avenue in Nashville and works closely with our Clinical Research Department, giving research participants and ATC patients’ access to the newest therapies.
CORE RESPONSIBILITIES
Clinical Research Nursing
- Administer investigational products, study medications, and infusions/IV therapy in accordance with protocol requirements and physician orders.
- Perform or assist with study-related clinical procedures (e.g., injections, infusions, specimen collection, vital signs, ECGs, and urology-specific procedural support in coordination with the PI and clinical staff).
- Monitor research participants during and after study procedures or drug/device administration, recognizing and escalating adverse events per protocol and SOP.
- Provide participant education on study medications, procedures, potential side effects, and self-monitoring between visits.
- Maintain competency in venipuncture,
- Support infusion and procedural visits across the study portfolio as scheduling needs arise, not limited to a fixed caseload.
Advanced Therapeutics Center (ATC) Clinical Support
- Administer infusion therapy (non-chemotherapy) to ATC patients per provider orders and clinic protocols.
- Administer LHRH injections per provider orders.
- Monitor ATC patients for side effects before, during, and after treatment, and escalate concerns to the treating provider promptly.
- Provide attentive, compassionate nursing care to patients throughout their treatments.
- Stay current on all new ATC therapies as they are implemented, including completing the training required to administer and monitor them safely.
- Cover for the ATC RN when they are out of office. Additional ATC duties will be added as clinic need and your availability allow, in coordination with the Research Department Manager and ATC leadership.
Study Conduct & Team Coordination
- Partner with Clinical Research Coordinators to support day-to-day study conduct for assigned participants, including visit execution per the protocol Schedule of Events (SOE).
- Document all clinical care, medication administration, and procedural activity contemporaneously in the source record and applicable EDC/eSource system (e.g., CRIO).
- Coordinate with the Study Start-Up team during protocol activation to understand site-specific procedures, supply needs, and infusion/administration requirements for new studies.
- Work with the Regulatory team to ensure required source documentation and clinical records support ongoing regulatory submissions and continuing reviews.
- Identify, triage, and report AEs/SAEs and protocol deviations for assigned studies, in accordance with sponsor and IRB timelines.
- Support investigational product (IP) handling, storage, dispensing, and accountability alongside the study team.
Regulatory & Documentation
- Maintain source documentation in compliance with ALCOA-C principles and departmental SOPs.
- Document ATC patient care accurately and contemporaneously in the EHR per clinic policy.
- Support audit and monitoring visit readiness by ensuring clinical documentation is accurate, complete, and available for review.
Collaboration & Communication
- Serve as a clinical resource to the research and ATC teams on nursing-scope procedures, medication administration, and patient safety questions.
- Communicate proactively with the Clinical Research Department Manager on scheduling, workload, and any clinical concerns affecting study conduct or ATC coverage.
- Collaborate with front-office, procedural, and clinical staff across Urology Associates to coordinate research visits and ATC treatments within the flow of clinical operations.
- Work as part of a team to cover studies and patient care as assigned, helping care for all patients as needed.
QUALIFICATIONS
Required
- Active, unencumbered Registered Nurse (RN) license in the State of Tennessee (or active multistate compact license recognized by TN).
- Minimum of one (1) year of clinical research experience.
- Demonstrated ability to perform IV therapy/infusion administration and injections (formal IV therapy certification is not required if competency can be demonstrated and verified through prior clinical experience).
- Comfortable working across research and clinic settings and flexing between studies and ATC patient care as needs arise.
- Strong understanding of, or ability to quickly develop proficiency in, Good Clinical Practice (GCP) principles and applicable FDA/ICH-GCP regulations.
- Excellent clinical judgment, attention to detail, and documentation practices.
- Strong interpersonal and communication skills for working with patients, participants, physicians, sponsors, and monitors.
Preferred
- Prior experience in a urology, oncology, infusion, surgical, or procedural clinical setting.
- Experience with electronic data capture (EDC) or eSource/eRegulatory platforms (e.g., CRIO, REDCap, Medidata).
- CCRC (ACRP) or CCRP (SOCRA) certification, or willingness to pursue certification with departmental support.
- BSN (Bachelor of Science in Nursing).
LICENSURE, CERTIFICATIONS & TRAINING
- Urology Associates covers the cost of required licensure, certifications, and training, and will maintain them for you while you are employed with the practice.
- GCP/CITI training required within 90 days of hire, consistent with departmental onboarding standards for all clinical research staff.
- Medtrainer assigned task required within 90 days of hire, consistent with departmental onboarding standards for all clinical research staff.
- IATA certification (biological specimen shipping) required within 90 days of hire, if applicable to assigned protocols.
- Ongoing protocol-specific training as assigned by the Clinical Research Department Manager or sponsor/CRO.
- Ongoing ATC therapy training as new therapies are implemented.
PHYSICAL REQUIREMENTS
- Ability to stand, walk, and move throughout clinical, procedural, and infusion areas for extended periods.
- Ability to perform clinical tasks requiring manual dexterity, including venipuncture, IV placement, and injections.
- Occasional lifting/moving of up to 25 lbs. (e.g., supplies, equipment).
- Ability to respond quickly to patient and participant safety needs during procedures and infusions.
