Clinical Research Assistant

2 weeks ago

Knoxville, United States Provision Healthcare Full time
Job DescriptionJob Description

SUMMARY OF POSITION:

This position provides support to ensure a smooth day-to-day operation of the Clinical Trial program. Conduct research activities, under general direction of Clinical Trial Manager, to assist research staff with maintaining study materials such as lab kits, shipping supplies, ECG equipment, and devices provided by the study sponsor. Assist in maintaining essential regulatory and study-related documents by filing in appropriate study binders and/or Clinical Trials Management System (CTMS). Perform tasks as needed to promote daily study conduct as required by ICH-GCP Guidelines and FDA Regulations.

JOB RESPONSIBILITIES:

  • Assist in maintaining essential regulatory and study-related documents
  • Record study information within Clinical Trials Management System (CTMS) to ensure proficient flow of patient care, documentation of study visits, and creating invoices as necessary for study activities
  • Maintain daily temperature logs and report excursions as needed
  • Coordinate staff credentialing to ensure that CVs, Medical Licenses, and Good Clinical Practice certificates are current
  • Receive and maintain Investigational Product as required by study protocol
  • Assist research staff in processing lab specimens as required by study protocol or laboratory manual. Obtain dry ice as needed for shipment. Prepare specimens and ship according to IATA requirements
  • Assist research staff in preparing and/or performing study procedures such as ECG
  • Blood draws as may be required by study.
  • Maintain inventory of study materials such as lab kits, shipping supplies, ECG equipment, and devices provided by study sponsor. Pull expired materials and submit resupply requests to ensure adequate supply for study visits
  • Assist in organizing special projects as needed for the Clinical Trial program
  • Perform other duties as assigned by Clinical Trial Manager

JOB SPECIFICATIONS:

  • Minimum Qualifications
    1. Graduate of an accredited;
      • Community college with an Associate’s degree, required or
      • College or university with a Bachelors degree of science, preferred
      • Nursing degree accepted but not required
    • Successful completion of all assigned research training
  • Required Experience & Skills
    • Experience in a healthcare setting
    • Phlebotomy skills
    • Ability to manage multiple tasks and prioritize accordingly
    • Possess excellent written and oral communication skills
    • Act as team player with positive attitude and excellent interpersonal skills
    • Proficient in PC and Microsoft Office
    • Ability to gather, organize, and verify data for projects
    • Maintain confidentiality of data and patient information according to HIPPA regulations
  • Work Environment:
    • Indoor outpatient office setting
    • Clinical procedure areas

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