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.
Job Tags
Interim role,