Clinical Studies RN II, Surgery Trauma

Overview

JOB SUMMARY

The Clinical Research Nurse II works on multiple Trauma Studies including burn studies, Level One Trauma studies,  Ventilator related Studies, and Pediatric Studies. The Studies involve going to the Operating Room, Intensive Care Units, Trauma Clinic  and or  the Emergency Department. None of these studies are funded by grants,  they are industry, NIH and Department of Defense funded.  Some of the studies are investigator initiated and others are industry sponsored.

Provides specialized nursing care/treatment to a specific group of patients who are participating in clinical research studies within the Surgery/Trauma department of Atrium Health Wake Forest Baptist. Functions as part of a research team that may consist of Investigators, Clinical Studies Coordinators, Data Managers, Regulatory Coordinators, and other Nursing Staff. Under the direction of the Investigator, the Clinical Research Nurse II is responsible for subject recruitment, eligibility, enrollment, informed consent, retention, education, and protocol adherence. Clinical responsibilities include monitoring toxicities, assessing clinical response and providing exemplary patient care while ensuring the protocol is conducted in a high-quality manner. Conducts clinical research in compliance with Clinical Protocol and Data management (CPDM) unit, State, and Federal guidelines. In addition, communicates research-related information to patients, families, nursing, and medical staff as necessary. Cross trains to support the other Clinical Studies Nurses when needed.

EDUCATION/EXPERIENCE

Associate's degree in Nursing from an accredited School of Nursing with one year of nursing experience, preferably in a related field, research, acute care, or a specialty area. Bachelor's degree in Nursing with two or more years of nursing experience preferred.  Clinical Research experience is mandatory.

LICENSURE, CERTIFICATION, and/or REGISTRATION

• Licensure as a Registered Nurse (RN) in the State of North Carolina required.
• Must complete the CITI certification for Human Subject Research if not already completed and any additional required WakeOne training for research coordinators.

ESSENTIAL FUNCTIONS

1. Works under the direction and supervision of Dr. James  Holmes IV  and  the Study Investigators. Also receives supervision and mentoring from the Study Team.
2. Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research and care of participants.
3. Actively screens Burn and Trauma patients for eligibility.
4. Actively carries out Study protocol interventions (which may include ultrasound, administering study medication, drawing blood,  responding to  Level 1 Trauma Codes, familiarity with Operating Room protocol, coordinating study visits and procedures, etc.).
5. Coordinates patient schedules and provides information for a successful visit to meet the required protocol procedures, data collection time points and nursing care.
6. Interacts with critically ill Trauma and Burn victims and their families.
7. Coordinates with the physician and clinic staff to assure that all protocol requirements are scheduled and ordered.
8. Reviews Electronic Medical Record to ensure protocol compliance and appropriate data collection.
9. Assesses and enter the initial adverse event report and serious adverse events into the eIRB system e. Follows-up with the assigned regulatory contact to resolve any outstanding reporting requirements in a prompt and appropriate manner 
10. Attends relevant investigational and professional meetings to keep abreast of current developments in the field.
11. Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and others. 
12. Performs other related duties incidental to the work described herein.

SKILLS/QUALIFICATIONS

• Good oral, written, listening, and interpersonal and communication skills
• Ability to provide indirect patient care
• EPIC/Encompass proficiency to include appropriate documentation of research notes
• Basic computer skills required

WORK ENVIRONMENT

• Fast paced, long hours, ability to deliver results
• Professionalism and customer service skills being a must at all times
• Occasionally subject to irregular hours