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Optometry Clinical Research Coordinator

Optometry Clinical Research Coordinator

ICON Strategic SolutionsJohns Creek, GA, US
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Job Description

We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our optometry-focused research team in Johns Creek, GA . This role is ideal for someone passionate about advancing eye care through clinical studies and patient-focused research.

Job Description

  • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 0%) domestic and / or international.
  • Communicate protocol requirements to clinical and laboratory staff.
  • Participate in the early planning phases of clinical study by providing assistance in the preparation of study proposal timelines, scheduling and other study requirements as appropriate.
  • Evaluate, coordinate, and ensure the completion of all protocol related tasks to include : design of procedural timeline; design of forms and source documents used in the clinical research process; maintain clinical study enrolment log; and assist Data Coordinators regarding CRFs and regulatory documents.
  • Obtain input of the clinical staff as it pertains to the development of the source documents, forms, and procedural timelines.
  • Coordinate with Study or Project Manger to ensure appropriate timelines are being met as per contractual obligations.
  • Attend meetings with Sponsors for assigned protocol.
  • Participate in meetings to include (pre-planning and clinical tracking).
  • Assure resolution of all Quality Control discrepancies related to data and research documents.
  • Lead and coordinate interdepartmental start up meetings, and mock runs to ensure that all clinical staff is trained on protocol procedures.
  • Coordinates with Screening and Recruitment to maintain timely execution of study enrolment.
  • Coordinate and ensure with Data Management to ensure timely submission of regulatory documents to IRB and CRF completion.
  • Coordinate with Study or Project Manager to provide requested information for interim status report to sponsor.
  • Carry out clinical study directives from the Principal / Sub Investigator.
  • Understand protocol requirements and communicate those requirements to applicable staff.
  • To undertake other reasonably related duties as may be assigned from time to time.

What you will be doing

  • Facilitating the coordination and execution of clinical research studies, including participant recruitment, enrollment, and follow-up activities.
  • Collaborating with principal investigators, study sponsors, and regulatory authorities to ensure compliance with study protocols, regulatory requirements, and ethical standards.
  • Collecting and maintaining accurate and complete clinical trial data, including documentation of adverse events, protocol deviations, and study outcomes.
  • Managing study-related documentation, including informed consent forms, case report forms, and regulatory submissions.
  • Providing support and guidance to study participants, including education, counseling, and assistance with study-related procedures.
  • Your profile

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field.
  • Previous experience working in clinical research or healthcare settings preferred.
  • KNwledge of clinical research regulations, including FDA / EMA regulations, ICH-GCP guidelines, and HIPAA requirements.
  • Strong organizational, communication, and interpersonal skills, with the ability to work effectively in a team environment.
  • Detail-oriented with the ability to manage multiple tasks and priorities simultaneously.
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    Clinical Research Coordinator • Johns Creek, GA, US

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