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Clinical Research Technician – PM or NOC/FT or PT

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: 02 Nov 2015

Job Summary:
Responsible for advanced technical procedures (such as, but not limited to, meal administration,
subject positioning, bag check, vital signs, ECG lead placement, phlebotomy, urine collection,
PK runner, height/weight/BMI, dose verification) 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.
  • 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.
  • Performs dose verification, assisting Clinical Research Nurses during dose administration to
    accurately verify subject identity and dosing labeling, as additional quality check.
  • Report any subject complaints of adverse events immediately to Charge staff or Clinical
    Research Nurses to ensure appropriate evaluation and treatment.
  • 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.

Job Description
Spaulding Clinical Confidential 2
Clinical Research Technician – Advanced

  • 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.

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.

  • 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.

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 identify and distinguish colors.

Hazards:

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

Education and Experience:

  • Associate’s Degree in a scientific/medical discipline desirable
  • Phlebotomy Certificate or associated real-world (on-the-job training) experience required
  • Certified Nursing Assistant or Medical Assistant certification highly desirable
  • CPR certification required within one year 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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