Job Description

Summary: The Clinical Dialysis Research Nurse provides nursing standard of care in a research environment, specifically related to dialysis treatments. The nurse is responsible for monitoring study participants, which includes collecting and reporting data on changes in their physical and mental status, monitoring drug actions and side effects, collecting lab samples, dispensing, and accounting for investigational products assigned. The Dialysis Research Nurse provides support to the Clinical Research Coordinator in conducting the inpatient portion of clinical trials, with the extent of duties determined by experience, assignment of duties in the site delegation log, training, and licensure.

Duties and Responsibilities: The Clinical Dialysis Research Nurse:

• Obtains, processes, and ships laboratory samples (e.g., blood, urine, etc.) as per protocol, with a focus on samples relevant to dialysis treatments.
• Assists and supports patient education on the completion of dialysis-related diaries, questionnaires, and logs required in the trial (if applicable).
• Provides nursing standard of care in subjects admitted and seen in a clinical research setting, with supervision from the Clinical Research Nurse-Registered Nurse (when applicable) during dialysis treatments.
• Ensures subjects’ safety and compliance with the protocol-specific lifestyle guidelines related to dialysis.
• Obtains and maintains intravenous access on subjects admitted for dialysis-related clinical trials.
• Administers investigational products during dialysis treatments as per protocol.
• Assesses adverse events and drug reactions related to dialysis and seeks medical intervention for patients when appropriate.
• Reports all adverse events (AEs) and serious or unexpected adverse events (SAEs) to the investigator and assists the Investigator in reporting to the Sponsor/IRB all AEs/SAEs, as required by the protocol and regulations.
• Performs all protocol-related procedures, including but not limited to vital signs, ECGs, phlebotomy, finger sticks, mouth swabs, spirometry, urine dipsticks, drug screens, pregnancy tests, etc., during dialysis research visits.
• Adequately documents study procedure collection via progress notes, adverse event information observed and/or reported, along with dialysis-related procedures performed during clinical trials.
• Obtains lab reports, procedure reports, and ensures the investigator reviews all lab results, including full signatures and providing clinical significance to any out-of-range or abnormal values in dialysis treatment results.
• Dispenses and monitors allowed concomitant medication intake during the dialysis research protocol.
• Dispenses and monitors cigarette intake as per study guidelines for dialysis patients.
• Manages inventories of medical supplies related to dialysis care.
• Conducts quarantine and recall procedures for dialysis-related supplies and medications.
• Maintains crash cart inventory and contents, ensuring all dialysis-related emergency equipment is available and properly stocked.
• Facilitates DRP and ER plans in the event of an emergency during dialysis procedures.
• Attends site initiation visits and/or training in-service for all protocols, specifically those involving dialysis treatments.
• Maintains current Safe-t-pack biohazard training certification or IATA equivalent, ACLS certification for RNs, OSHA, and site’s SOP (SWP) training.
• Has in-depth knowledge of company SOPs, ICH GCP guidelines, and protocols assigned, specifically the inpatient segment, safety criteria, and dialysis care requirements.
• Assists in documentation of medical and surgical history, concomitant medication use, preliminary complaints, and lifestyle practices of dialysis patients.
• Documents inpatient activities, progress notes, adverse events observed and/or reported, and dialysis-specific procedures performed during clinical trials.
• Supports the reinforcement of study restrictions, diets, and study guidelines for dialysis patients.
• Assists in obtaining lab reports, procedure reports, and filing, specifically those collected during Day -1 or unscheduled dialysis-related activities.
• Assists in the preparation of collection tubes, vials, and study supplies for dialysis-related visits, including PK/PD setups.
• Continuously observes and monitors dialysis patients to ensure safety and compliance with the protocol, restrictions, and specific dialysis-related guidelines.
• Conducts assessment procedures as required by the protocol (vital signs monitoring, electrocardiogram, etc.) under CRC and/or nurse supervision during dialysis sessions.
• Maintains inpatient temperature freezer, refrigerator, and room logs to ensure proper storage of dialysis-related medications and samples.
• Reports temperature excursions for dialysis-related medications and supplies.
• Occasional travel to company sites, Principal Meetings, and/or company meetings may be required.
• Performs other duties as assigned.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

• Active Registered Nurse (RN) or Licensed Vocational Nurse (LVN) licensure.
• Previous research experience and/or background, especially in dialysis care, is required.
• ACLS certification for RNs.
• Basic Cardiac Life Support (BCLS) certification.
• The Dialysis Research Nurse is expected to maintain nursing license, ACLS certification for RNs, and a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, and dialysis-specific protocols.

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• IATA (dangerous goods handling) – Must renew every 2 years

Competency Requirements:

• Strong organizational and time management skills.
• Excellent attention to detail and ability to maintain accurate records.
• Effective communication skills, both written and verbal.
• Ability to work independently and collaboratively in a team environment.
• Proactive problem-solving skills and adaptability in a dynamic setting.

Technical Competency Requirements:

• Understanding of ICH/GCP guidelines for human research
• Understanding of Code of Federal Regulations for Human Subject
• Computer Competency in Electronic Data Capture
• Understanding Phases I-IV drug development process.
• ECG, Phlebotomy skills and other technical skills related to completion of study visits as required by the protocol.

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift 20 pounds at a time.
• Exposure to human bodily fluids.
• Laboratory Processing Procedures.
• Subject/Patient Care
• Mid-level Computer use.
• Weekend work schedules as needed.
• Work is normally performed in a typical interior clinical/office environment.
• Travel to sponsor required meetings as needed.

Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

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