Clinical Research Coordinator - 248861

**SEEKING A CLINICAL RESEARCH COORDINATOR IN APPLETON, WI**

Location: Appleton, WI

Pay range: $50,000-$75,000

*Full benefits

Clinical Research Coordinator – Key Responsibilities:

• Facilitate and coordinate daily clinical trial activities, ensuring protocol adherence and study integrity.
• Administer sponsor-required questionnaires, such as the VFQ, according to study timelines.
• Collaborate with designated team members to ensure adequate inventory of study supplies, lab kits, and shipping materials.
• Ensure study staff are properly trained on protocol-specific procedures, informed consent forms (ICFs), and study manuals; document all training accordingly.
• Create, manage, and maintain accurate source documents for each clinical trial.
• Attend sponsor teleconferences and Investigator Meetings as assigned by the research director.
• Review and comprehend study protocols, including timelines, inclusion/exclusion criteria, and confidentiality protections.
• Collaborate with study and clinical teams to recruit, screen, and enroll eligible participants in alignment with study enrollment goals.
• Accurately screen subjects based on inclusion/exclusion criteria and document eligibility findings.
• Complete delegated study-related tasks such as scribing, administering VFQ, and measuring intraocular pressure (IOP).
• Collect and update medical histories, and report adverse events (AEs) and serious adverse events (SAEs) to the sponsor and IRB within required timelines.
• Conduct and/or participate in informed consent discussions with participants; ensure understanding and address questions.
• Implement and verify use of amended consent forms; act as a secondary reviewer to ensure accurate ICF execution.
• Collect study data per protocol guidelines and enter data into Electronic Data Capture (EDC) systems within the contracted timelines.
• Oversee the accuracy of entered data, resolve data queries promptly, and ensure all EDC entries are compliant with protocol and sponsor expectations.
• Collect and report all Adverse Events (AEs), Serious Adverse Events (SAEs), and SUSARs in compliance with regulatory guidelines.
• Coordinate and prepare for monitor site visits; assist with the completion and submission of visit documentation.
• Collaborate with monitors to address and correct findings in a timely manner.
• Manage and maintain regulatory documentation, including protocols, investigator brochures, IRB approvals, disclosures, CVs, and training records.
• Obtain and maintain required sponsor trainings and certifications as applicable to assigned clinical studies.