Clinical Research Assistant (32212) in Lafayette, Louisiana at GI Alliance

Industry: Healthcare / Health ServicesJob Function: Medical
GI Alliance
Lafayette, Louisiana, 70501, United States
Posted on

Job Description

Clinical Research Assistant (32212)
Job DetailsJob Location: Southern Urology Main Lafayette - Lafayette, LA 70508
Position Type: Full Time
Job Shift: Day
Description

Description


  • Read and understand specific requirements of each study protocol and informed consent form
  • Works with study coordinators and other research team members to complete protocol specific procedures and documentation
  • Assists in clinic and protocol administration duties including but not limited to:
    • Explain the purpose, risks, and benefits of clinical trial participation
    • Screen potential candidates in a timely and accurate manner
    • Ensure that study patients understand the information presented and agree to the protocol requirements
    • Obtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standards
    • Provide instructions to patients to ensure proper protocol compliance
    • Distribute study medications in compliance with protocol randomization requirements
    • Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)
    • Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements

  • Explain the purpose, risks, and benefits of clinical trial participation
  • Screen potential candidates in a timely and accurate manner
  • Ensure that study patients understand the information presented and agree to the protocol requirements
  • Obtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standards
  • Provide instructions to patients to ensure proper protocol compliance
  • Distribute study medications in compliance with protocol randomization requirements
  • Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)
  • Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements

    • Perform study-specific readings and measurements including but not limited to:

  • Perform study-specific readings and measurements including but not limited to:

  • Vital signs
  • ECG
  • Urine Pregnancy Test
  • Uroflow, TRUS, urinalysis, cystoscopy
  • Photography and videography

  • Reports irregular readings and measurements to Investigator and Lead Study Coordinator
  • Package and ship laboratory specimens to study-specific destinations
  • Complete applicable training requirements and ongoing education as required

  • Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
  • Communicate with and support patients and their families as necessary.
  • Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records
  • Effectively communicate with potential candidates for trials and collect metrics to track progress
  • Must have or gain knowledge of relevant software/programs


  • Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls
  • Assist with the development of source documents and phone screen tools
  • Manage ancillary supply inventory and assist with drug accountability
  • Maintain HIPAA compliant communication and confidentiality, at all times
  • Participate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.
  • Assist study coordinators with necessary study close-out procedures and documentation
  • Performs other duties as assigned

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    Job Location

    Lafayette, Louisiana, 70501, United States

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