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Clinical Research Nurse – AM

SPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe.

Original Date: 27 Oct 2009
Revision Date: 08 Feb 2021

Job Summary:
Responsible for advanced nursing activities such as, but not limited to, Informed Consent
documentation, medical history, AE/CM, drug administration/accountability, dose verification,
focused subject physical assessments, collaborate with the medical team, IV placement, IV
infusions, vital signs, ECG lead placement in the conduct of clinical trials with emphasis on the
safety and welfare of study participants. Performs the practical activities of clinical studies
according to protocol, regulatory requirements, SOPs, scope of practice and current training
status.

Essential Duties and Responsibilities:

  • With supervision, ensures that clinical trials are conducted according to protocol
    requirements by utilizing the following techniques & procedures.
  • 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 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 (the right subject, the right drug, the right
    dose, the right route, and the right time)

Job Description
Spaulding Clinical Confidential 2
Clinical Research Technician – Advanced

  • 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.

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications:

  • Ability to read, write, and interpret the English language
  • 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
  • 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.

Job Description
Spaulding Clinical Confidential 3
Clinical Research Nurse – Advanced
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job Description
Spaulding Clinical Confidential 3
Clinical Research Technician – Advanced
Accommodations may be made to enable individuals with disabilities to perform the essential
functions.

  • Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to
    handle or feel.
  • Ability to lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include clarity of vision both near and far.
  • Ability to identify and distinguish colors.

Hazards:

  • Potential for exposure to toxic or caustic chemicals
  • Potential for exposure to blood borne pathogens

Education and Experience:

  • 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)
  • CPR certification required within 6 months of hire or promotion date
  • ACLS certification required within 6 months of hire or promotion date

Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

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