Clinical Research Coordinator

CNY Fertility Center•Sarasota, FL
•$27 - $29

About The Position

CNY Fertility is a fertility center offering treatments including IVF, IUI, and egg freezing. The Clinical Research Coordinator assists with screening, financial matters, and planning related to clinical trials. The role manages recruitment, screening, and enrollment across multiple trials; supports participants with grant applications and expense monitoring; and works with the principal investigator and research nurse on IRB submissions and approvals. The coordinator interacts with patients throughout the study process, reviews informed consent and eligibility, monitors adverse events and protocol adherence, and prepares records for audits. The role may also support funding development, sponsor and institutional negotiations, grant compliance, and annual progress reports.

Requirements

  • Bachelor’s degree required.
  • High school diploma or GED; one to three years of related work experience.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence and speak effectively before groups of customers or employees.
  • Ability to perform arithmetic with whole numbers, common fractions, and decimals; compute rates, ratios, and percentages; and draw and interpret bar graphs.
  • Ability to solve practical problems and interpret written, oral, diagrammatic, or schedule-form instructions.
  • Strong critical-thinking and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to exercise sound judgment, make informed decisions, and work independently within established guidelines and general direction.

Responsibilities

  • Manage recruiting, screening, and enrollment of patients for multiple clinical trials while ensuring compliance with federal, state, and institutional guidelines.
  • Assist participants with grant applications and monitor expenses for all protocols.
  • Work with the principal investigator and research nurse to submit protocols, amendments, notices, suspensions, and terminations to the IRB for review and approval.
  • Interact with patients before study entry and throughout the process.
  • Discuss, obtain, and review informed consent forms to ensure compliance with federal, state, and IRB guidelines.
  • Check eligibility criteria using patients’ medical records and verify questions with the clinical research nurse or principal investigator.
  • Monitor adverse events and report them according to FDA guidelines and requirements of the sponsoring pharmacy and IRB.
  • Monitor physicians’, nurses’, and patients’ adherence to protocols.
  • Prepare records for audits.
  • May assist the principal investigator in obtaining new funding sources and negotiating with prospective sponsors and collaborating institutions.
  • Ensure compliance with funding agencies and assist the principal investigator in preparing annual grant progress reports.
  • Perform other duties as assigned, consistent with the role and operational needs of the organization.

Benefits

  • 401(k)
  • Dental insurance
  • Vision insurance
  • Health insurance
  • Life insurance
  • Flexible spending account
  • Paid time off
  • Maternity leave
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