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.