REGISTERED NURSE ADVANCED NOC SHIFT

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

3d•Onsite

About The Position

This is a full-time NOC position for an RN Advanced. The role is responsible for advanced nursing activities in the conduct of clinical trials, with an emphasis on the safety and welfare of study participants. This includes tasks such as Informed Consent documentation, medical history, Adverse Events/Concomitant Medications (AE/CM) management, drug administration and accountability, dose verification, focused subject physical assessments, collaboration with the medical team, IV placement and infusions, vital signs monitoring, and ECG lead placement. The nurse performs practical activities of clinical studies according to protocol, regulatory requirements, Standard Operating Procedures (SOPs), scope of practice, and current training status. Additionally, there is a charge nurse component responsible for overseeing daily clinical operations on the study floor, ensuring adherence to protocols and SOPs, coordinating and delegating activities of clinical staff, and providing leadership in clinical problem-solving. This includes maintaining a professional atmosphere, updating management on study-related issues, documenting and escalating Adverse Events, administering study drugs, performing dose verification, ensuring proper drug storage, completing shift duties, and working with the training department for process monitoring.

Requirements

Ability to read, write and interpret the English language.
Current RN or LPN License (Graduate Nurses must possess a temporary license in order to work as CRN, and must obtain Wisconsin licensure within 6 months of hire).
BLS certification required within 6 months of hire or promotion date.
Medical background required, with skill set appropriate for role.
Must be trained (or in-training) as Clinical Research Technician - Advanced or Clinical Research Nurse - Advanced.
Has demonstrated effective professionalism, leadership, and problem-solving skills as clinical floor staff for approximately 6 months at Spaulding Clinical, OR exceptional outside experience (previous charge, supervisory and/or leadership position) that would translate to a Charge role immediately upon hire.
CPR certification required within one year of hire or promotion date.
ACLS certification may be required within one year of hire or promotion date.

Nice To Haves

Portrays professionalism in all interactions at Spaulding Clinical.
Good computer skills; inclination to adopt technology to maximize efficiency.
Demonstrates strong analytical, problem solving skills.
Strong written and verbal communication skills.
Detail oriented, good organizational traits.
Self-motivated.
Must be results-oriented, multi-tasking, quick learner, respond to the urgent needs of the team, and show a strong track record of meeting deadlines.
Ability to work beyond normal work hours and various shift availability required.
Ability to perform and record data entry via computer systems while conducting timed clinical procedures.
Must show ability to stay up-to-date on all available trainings.
Excellent time management skills.
Demonstrates effective leadership traits with ability to direct and delegate.
Must be reliable and responsible for attending scheduled shifts, along with flexibility for higher study activity demands.
Proficient computer skills; inclination to adopt technology to maximize efficiency.
Strong attention to detail.
Demonstrates ability to adapt to a rapidly changing study environment.

Responsibilities

Ensures that clinical trials are conducted according to protocol requirements.
Ensures subject has complete understanding of study-specific Informed Consent Form and that all questions have been answered.
Accurately documents and records completion of Informed Consent.
Obtains and accurately documents structured subject medical, surgical and medication history.
Performs meal administration, ensuring the correct meal and correct content is delivered to the correct study participant.
Performs subject bag checks to ensure no contraband is present on study floor.
Performs study activities such as ECG positioning, exercises, or other study procedures requiring supervision of subjects.
Performs venipuncture, capillary, and/or IV specimens from study subjects according to established protocol, maintains aseptic technique.
Performs proper and accurate sample management, including collection, identification, transport, and/or processing of biological (blood, urine, etc) subject samples.
Administers study drug and any other protocol-required medications, while accurately ensuring the 5 Rights of Medication Administration.
Performs dose verification, assisting other Clinical Research Nurses during dose administration to accurately verify subject identity and dosing labeling, as additional quality check.
Contributes and is accountable for secure and appropriate storage of all drug supplies after removing from pharmacy.
Records subject Adverse Events with proper escalation to medical or Charge Staff for evaluation and treatment as warranted.
Performs and records physical measurements including height, weight, and BMI calculation.
Performs and records vital sign measurements (blood pressure, pulse oximetry, heartrate, temperature, respirations, etc).
Places ECG electrodes and leads accurately to ensure precise telemetry monitoring.
Performs additional task list items as delegated and supervised by Charge Staff.
Reviews Study Specific Trainings and applicable protocols for a thorough understanding of the study procedures, as they apply to their role and ensures that Delegation of Authority/Training Log for each study is completed in a proper and timely manner.
Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
Observes and maintains all HIPAA, OSHA, and Exposure Control regulations and Emergency Response as required by applicable training.
Creates and maintains accurate records of all protocol activities and events, as delegated and trained.
Follows progress of volunteers and provides for their care, comfort and safety by attending to their needs during study participation.
Participates in quality assurance of clinical research projects and initiates the need for same as it impacts on clinical practice.
As required for study or site needs and if trained and delegated may be assigned study procedures such as obtaining participant information/histories/questionaries/meals/vital signs/EKGs/drug administration/specimen collection/luggage searches.
Oversees daily clinical operations on clinical study floor and ensuring all studies are conducted according to study protocols and Spaulding Clinical SOP’s.
Works closely with Clinical Research Coordinators, Study Manager and Clinical Floor Supervisors to ensure studies are conducted according to study specific operational plans.
Coordinates, organizes, monitors and delegates daily activities of Clinical Staff assigned to study floor events, ensures adherence to policies and procedures and provides leadership and professionalism in clinical problem solving.
Maintains calm, professional atmosphere on study floor, leading by example with professional resolution of conflict and appropriate delegation.
Ensures that Study Manager and Clinical Floor Supervisors are updated and escalates study related issues that arise on the study floors with urgency, if needed.
Communicates all other issues as warranted to the appropriate department.
Ensures all shift duties are completed according to Charge Checklist or equivalent, including completion of all applicable logs and metrics.
Works with colleagues to achieve departmental goals as delegated.
Maintains knowledge of company goals to assist all floor staff in their development and engagement.
Maintains a clean, quiet study environment in all study areas.
Works with Training Department to perform and document Process Monitoring to ensure staff compliance and adherence.