Clinical Research Assistant (LPN)

Healthstar/CPS•Morristown, TN
•Onsite

About The Position

The Clinical Research Assistant (LPN) will perform patient assessments, draw and process specimens, perform various clinical procedures, and manage study-related paperwork. This role requires knowledge of electronic medical records, maintaining patient confidentiality, and adhering to all relevant regulations and guidelines. The assistant will also be responsible for inventorying supplies, maintaining drug accountability, and ensuring all training is up-to-date. Additionally, the role involves recruiting research participants and maintaining data integrity.

Requirements

  • Current competencies applicable to the position.
  • Knowledge of phlebotomy techniques.
  • Knowledge of clinic protocols and policies.
  • Good computer skills.
  • Demonstrate current competencies (efficient and effective blood draws) applicable for the position.
  • Knowledge of clinic/medical practice procedures.
  • Excellent written, verbal communication, and people skills.
  • Skilled in customer service and have a pleasant and courteous demeanor.
  • Ability to respond to stressful or emergency situations in a calm and effective manner.
  • Ability to work cooperatively as a member of office staff and team.
  • State Certification as LPN.
  • Must complete GCP, human subjects, Elligo and IRB and specific training for each protocol.
  • Certification LPN and CPR.

Nice To Haves

  • Other job functions as directed.

Responsibilities

  • Perform patient assessment on every study patient.
  • Draw, process, and send specimens to the central study lab per protocol.
  • Perform venipuncture, arterial, and capillary punctures on patients of all ages and conditions.
  • Identify and label specimens per protocol, including PK samples, urine pregnancy tests, COVID, and Flu tests.
  • Perform protocol procedures such as EKGs, Holter monitors, spirometry, and breathing tests.
  • Enter data into electronic medical records and complete study protocol paperwork and request forms.
  • Clean and sterilize equipment and work area following safety, cleanliness, and infection control procedures.
  • Inventory lab and other supplies and place orders.
  • Maintain drug accountability record sheets and input accountability into EMR systems.
  • Learn study-specific EMR systems (e.g., IntElligo, Medidata, Inform).
  • Maintain patient confidentiality.
  • Oversee and complete all trial paperwork on time.
  • Complete individual trial education and keep Clinical Trial Training up-to-date (GCP, Ethics, Human Protection, ICH, Informed Consent, Quality Assurance, Participant Safety, Adverse Events).
  • Ensure compliance with government, state, and IRB regulations and standards.
  • Ensure compliance with ICH/GCP guidelines.
  • Assist study manager/coordinator in entering data into study EMR systems, Elligo EMR system, and central lab.
  • Obtain flu, strep, and Covid swabs per protocol and be knowledgeable of protective safety attire.
  • Maintain regular and punctual attendance.
  • Recruit research participants.
  • Maintain quality standards, ensuring the integrity of the data.
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