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Flourish Research LTD - Gurnee, IL

posted about 2 months ago

Full-time
Gurnee, IL

About the position

The Quality Control Data Entry Specialist at Flourish Research is responsible for ensuring the accuracy and completeness of patient files by validating and entering data using the RealTime CTMS. This role is crucial in maintaining healthcare quality and regulatory standards, and while a clinical research background is preferred, it is not mandatory. The position offers opportunities for growth within a supportive and collaborative work environment.

Responsibilities

  • Represent Flourish in a professional and courteous manner when interacting with site staff, sponsors, IRBs, patients, and medical staff.
  • Conduct a thorough review of study charts utilizing SOPs, policies, GCP, GDP, and sponsor protocols.
  • Indicate missing or discrepant data points and report trends to the QC Manager and upper management.
  • Accurately enter data into an eCRF/CRF system according to sponsor guidelines in a timely manner.
  • Identify and report missing data points or inconsistencies to the clinical research coordinator and QC Manager.
  • Attend SIV meetings and report discrepancies between source and CRF/eCRF immediately.
  • Resolve open queries thoroughly and in a timely manner.
  • Assist in sponsor monitor visits to resolve queries.
  • Work closely with other staff members and sponsor representatives in a professional manner.
  • Assist with training onboarding procedures.
  • Perform all duties in a timely and cost-effective manner.

Requirements

  • Bachelor's degree or commensurate experience
  • At least 1 year of experience in quality and/or data entry in healthcare
  • Familiarity with patient databases, such as a CTMS
  • Understanding of ICH, FDA, and GCP regulations
  • Impeccable organizational skills and attention to detail
  • Excellent communication and interpersonal skills
  • High-level critical thinking skills
  • Working knowledge of medical terminology
  • Proficiency with computers and Microsoft Office Suite

Nice-to-haves

  • Clinical research experience
  • Experience working in a patient database

Benefits

  • 401(k) matching
  • Paid time off
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