Research Nurse III, Department of Internal Medicine (College of Medicine-Phoenix)

Study Coordination

• Participate in feasibility assessment of new studies by reviewing potential protocols, informed consent documents, and evaluate their effect on standard clinical research procedures.
• Screen and enroll participants:
• Assess patient eligibility based on protocol-defined eligibility criteria.
• Recruit study participants.
• Schedule appointments.
• Interview and evaluate potential participants to ensure they meet eligibility requirements.
• Obtain informed consent:
• Explain the study to participants.
• Obtain informed consent and address concerns.
• Visit scheduling:
• Coordinate patient appointments, procedures, and follow-ups as required per protocol.

Patient Care and Clinical Assessments

• Monitor participant health:
• Assess and record vital signs.
• Review lab results.
• Collect and report adverse events.
• Administer treatments/interventions:
• Provide study-related treatments or interventions in accordance with the protocol.
• Coordinate and/or perform physical assessments required by protocol.
• Perform lab draws and other protocol procedures.
• Administer injections where an RN license is required.
• Patient support:
• Serve as primary point of contact for participants and family.

Data Collection and Documentation

• Document medical data in patient record.
• Maintain original data related to the trial for audits and reviews.
• Assist physician and/or principal investigator in writing manuscripts for publication and/or presentation of materials at conferences.

Data Entry and Record Keeping

• Enter data into electronic databases ensuring accuracy and compliance with study timelines.
• Maintain detailed records of patient data, trends, labs, and other clinical data.
• Collect, report adverse events, and report study outcomes.

Regulatory Compliance and Reporting

• Ensure all study activities are conducted in compliance with IRB protocols, FDA regulations, and Good Clinical Practice (GCP) guidelines.
• Adverse event and protocol deviation reporting:
• Report and document adverse events and protocol deviations promptly.
• Monitoring visits:
• Prepare for sponsor visits and/or regulatory audits.
• Manage records and communication.

Collaboration and Communication

• Collaborate with principal investigators, research nurses, coordinators, and the healthcare team.
• Actively participate in clinical research team meetings.
• Assist in training/mentoring other research staff on study procedures or protocol amendments.
• Train, oversee, and provide current patient information to clinical nurses and other health care personnel in order to assure comprehensive patient care.

Patient Liaison

• Serve as the primary contact between participants and the study team.
• Evaluate and develop patient educational materials.
• Give patient and/or family members instructions on drug administration and other medical information.

Knowledge, Skills & Abilities

• Excellent written and verbal communication skills.
• Knowledge of the principles, practices, and techniques of clinical/translational research.