SUMMARY: The PRN Clinical Research Registered Nurse (PRN RN), under the guidance of the Associate Director, Clinical Conduct and the Medical Director, is responsible for protecting the health, safety, and welfare of research participants by observing strict adherence to local, state, and federal regulations, Worldwide Clinical Trials (WCT) policies and procedures, and the Nurse Practice Act. They will also assist in setting up and overseeing procedures on the floor, performing various study related procedures, and administrative duties as needed. The PRN RN works under the direct supervision and guidance of the Associate Director, Clinical Conduct. They will provide direction and indirect supervision for the Floor staff to include Paramedics, Phlebotomists and Research Technicians.
Tasks may include but are not limited to:
- Always represents WCT in a professional manner (to Sponsors, study participants and outside vendors).
- Under the direction of the Medical Director’s standing orders, functions as WCT’s medical coverage (along with on-duty Paramedics) in case of an emergency for subjects/patients visiting WCT.
- Reads, interprets, and seeks necessary clarification of protocols for all clinical studies conducted at WCT.
- Within the nursing scope of practice, assists the PI with the care and evaluation of participants as needed.
- Maintains adherence to SOPs and DOPs and ensures floor staff is compliant.
- Assists with writing new procedures when required by protocol.
- Assists with the development of, training for, and evaluation of the proficiency of procedures done in-house by nursing, paramedic, and ancillary staff.
- When available attends in-house procedure meetings and study initiation meetings.
- Works closely with the Manager, Clinical Study and Study Coordinator to ensure study procedures are performed according to protocol.
- Assists with performance of quality checks on source documents specific to the study.
- Assists with development of physician orders, dose criteria guidelines, and subject safety parameters in conjunction with their supervisor, Medical Director and/or Principal Investigator.
- Assists with subject qualification and AE documentation as needed.
- Utilizes knowledge of disease processes to observe, report, and intervene in adverse events in a timely and accurate manner to ensure the health, safety, and welfare of the study participant.
- Assists with staffing assignments, ensuring qualified, adequate personnel for study coverage.
- Assists with on-going in-process and retro-active quality improvement process by identifying supplemental training needs and ensuring its’ completion.
- Acts as a resource for all staff to ensure study procedures are completed per protocol requirements. Should be available to answer questions about staffing and protocol requirements.
- Adheres to policies and procedures to ensure confidentiality, privacy, and security of clinical research interactions and participant information, and responsible use of subject’s research database in compliance with Worldwide Clinical Trials Clinical Research Service’s policies.
- Assists with training new RN Team Leaders/Paramedics/Phlebotomists and other personnel by serving as a mentor.
- Assures appropriately trained staff members are in place to perform scheduled protocol procedures. If staff members are unavailable, performs procedures when necessary to assure compliance with protocol requirements.
- Responsible for requesting, scheduling and attending any training required for this position.
- Ensures all required training is completed and thorough documentation is on file before performing any procedures.
- Assists with ordering and stocking supplies.
- Assists with tracking and monitoring attendance of floor staff.
- Coaches research staff to enhance performance and writes incident reports when performance improvement is needed.
- Assists with emergency cart inventories as needed.
- Assists and plans logistics on procedure space and flow for upcoming studies.
- Performs other procedures/duties not mentioned, as required by specific study protocols.
- Completes all necessary training for their position, including SOPs, DOPs, skill verification, and maintaining required certifications.
- Able to perform basic nursing assessments and procedures.
- Strong customer service, interpersonal, communication, and leadership skills.
- Perform duties at a fast pace with attention to detail and without errors.
- Adaptable and possess excellent problem solving skills with the ability to predict and manage potential problems.
- Willing to perform repetitive tasks.
- Good medical judgment.
- Medical equipment as indicated by protocol or standing orders for the care of subjects and completion of study requirements.
- Office equipment used for communication and general office duties. Laboratory equipment used for the processing of laboratory samples. Food preparation equipment for the use of reheating meals.
Required: Associate Degree in Nursing with current licensure/certifications with at least 2 years of experience. 1 year Clinical Research experience.
Preferred: Bachelor’s Degree in Nursing with current licensure/certifications along with 2-3 years of supervisory experience and 2 years of clinical research experience.
- Maintains current ACLS and BLS certifications.
- The PRN RN will have a variety of tasks assigned to him/her, and he/she will be responsible for performing these tasks accurately and promptly. It will be the employee’s responsibility to notify their Supervisor if he/she is not able or is not trained to perform any assigned tasks, or of any other problems he/she encounter with the Floor staff or study participants. He/she is responsible for making sound medical judgments that are in the best interest of the participants, study conduction, and WCT.
- The absence of their Supervisor, he/she is also responsible for performing mediation with and between participants while continuing to ensure smooth study conduct and participant completion.
- The PRN RN will have a large amount of direct and unsupervised contact with study participants and Floor staff. They will be responsible for communicating problems, questions and/or clarifications to their Supervisor and Human Resources as appropriate.
- Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, participant contact, attention to detail, frequent interruptions, fluctuations in workload, performing very strict time-dependent procedures, multi-tasking, adaptability, attention to detail, problem solving, and planning ahead in order to foresee and handle potential problems.
- Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or bodily fluids, and/or hazardous fumes or chemicals.Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently
Job Type: Part-time
Pay: $30.00 per hour
- Nursing: 2 years (Required)
- Clinical Research: 1 year (Required)
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