Clinical Research Nurse

32 hours per week.
The Clinical Research Nurse engages in specialty professional nursing practice focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. Research nursing practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, clinical settings, and clinical specialties. Clinical Research Nursing has been recognized by American Nursing Association (ANA) a Specialty Practice since 2016.

JOB RESPONSIBILITIES:

The research nurse performs a wide range of professional, administrative, and clinical responsibilities requiring synthesis and sound judgement. The research nurse will:

• Manage clinical aspects of assigned research studies in collaboration with principal investigator.  
• Provide nursing care to study participants.
• Perform consent discussions with eligible participants as part of the consenting process.
• Obtain informed consent from participant or Legally Authorized Representative alone and/or with the investigator.
• Perform physical assessments, clinical procedures, and drug administration.  
• Prioritize and take action to maintain participant safety.
• Monitor outcomes with special attention to adverse reactions.
• Coordinate participant care and research services across providers and disciplines. 
• Report participant status to the investigator.
• Review medical records, collect data, chart in the participant medical record, and transcribe data into the study data capture system. 
• Follow participant progress from recruitment through research engagement, treatment, discharge, and follow-up.
• Evaluate educational needs and develop and implement educational programs and materials for participants, caregivers, and staff.
• Mentor clinical and research staff as the protocol and participant expert.
• Develop specific systems and documents to implement complex protocols.
• Collaborate with pharmacist for the management of investigational products (IP).
• Ensure best practices in the management of IP for drug, device, and biologic studies.
• Prepare data for transmission to collaborators/sponsor(s) and/or publication.
• Understand and adhere to research regulations.
• Prepare for and attend investigator meetings, sponsor monitoring sessions, site audits, and inspections. Ensure follow up actions are resolved.   
• Communicate with Institutional Review Board(s) and manage submissions.
• Maintain regulatory documents for assigned studies.
• Communicate often with and develop working relationships with study sponsors, collaborating medical centers, and academic institutions.

Other requirements:

• Practices proper safety techniques in accordance with Shepherd Center and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.  
• Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process.

REQUIRED MINIMUM EDUCATION:

• Bachelor of Science in Nursing.
• Graduate of an accredited school of nursing.

REQUIRED MINIMUM CERTIFICATIONS:

• Registered Nurse - Licensed as an RN in the single State of Georgia or Multi-State through the Enhanced Nurse Licensure Compact.
• Cardiopulmonary Resuscitation (CPR)

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REQUIRED MINIMUM EXPERIENCE:

• Minimum of five (5) years clinical nursing experience required.

REQUIRED MINIMUM SKILLS:

• Ability to provide competent and compassionate nursing care.
• Moderate to advanced computer skills.
• Superior written communication skills.
• Flexibility to work shift per protocol demands.
• Completes orientation and initial assessment of competency successfully by determined due date.
• Completes mandatory education and annual competency assessment requirements by determined due date.
• Human Subject Protection and Good Clinical Practices (GCP) Training
• Hazardous Material Shipping Training

PREFERRED QUALIFICATIONS:

• Research Certification (CCRC or CCRP)
• Clinical research experience preferred.

PHYSICAL DEMANDS:

• Physical ability to perform clinical nursing job functions requiring bending, reaching, lifting, walking, and standing. Ability to lift 60 pounds on occasion, stand for up to 4 – 6 hours daily, able to read text from distance and see/discern colors.

WORKING CONDITIONS:

• Some potential for exposure to blood, body fluids, investigational drugs, and investigational devices.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification.  They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.