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Clinical Research Associate

2 months ago

Maxwell, United States Medix™ Full time

Clinical Research Associate

Position Type: Full-Time

Reports To: Clinical Trials Supervisor

Compensation: $22 - $25/hour

Schedule: Monday - Friday

Position Overview:

The Clinical Research Associate plays a vital role in supporting patient research visits in accordance with ICH-GCP standards and the approved study protocols. Responsibilities may vary based on individual expertise and the organization's evolving needs.

Essential Qualifications:

  • High School diploma or equivalent, with considerable relevant experience
  • Preferred: College degree
  • Ophthalmic experience is a plus
  • Strong oral and written communication skills
  • Ability to provide safe and appropriate patient care in line with study protocols

Key Responsibilities:

  • Coordinate and schedule patient visits in alignment with study-specific timelines.
  • Prepare necessary documentation and charts for the Clinical Research Coordinator.
  • Assist the Coordinator in patient care and management activities.
  • Monitor subject flow and provide support in patient care.
  • Collect and document essential data during follow-up visits, including adverse events and concomitant medications.
  • Transfer subject study information from source documents to Electronic Case Report Forms.
  • Administer mandatory questionnaires to study participants.
  • Prepare subjects and conduct electrocardiograms (ECG) as per study requirements.
  • Request necessary medical records for Serious Adverse Event Reporting.
  • Process and ship biological samples for laboratory analysis.
  • Conduct intraocular pressure checks post-injections.
  • Perform trial frame refraction and ETDRS visual acuity testing when applicable.
  • Inform subjects and obtain written re-consents regarding informed consent forms.
  • Execute additional duties as assigned.
  • Complete any required sponsor training and certifications.