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.