Clinical Research Coordinator - 248861

Medix™; Appleton (WI); Presencial; USD 50.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Full benefits

Descripción de la vacante

A leading clinical research organization is seeking a Clinical Research Coordinator in Appleton, WI. The successful candidate will facilitate daily clinical trial activities, ensure protocol adherence, and manage the recruitment of participants. Responsibilities also include overseeing regulatory documentation and ensuring accurate data entry into Electronic Data Capture systems. The role offers a competitive salary range of $50,000-$75,000 and full benefits.

Formación

• Experience in coordinating clinical trials, ensuring protocol adherence.
• Familiarity with sponsor-required questionnaires and data collection methodologies.
• Ability to collaborate effectively with clinical teams and sponsors.

Responsabilidades

• Facilitate daily clinical trial activities and ensure protocol adherence.
• Coordinate study staff training on protocol-specific procedures.
• Recruit and enroll participants against study goals.

Conocimientos

Clinical trial coordination

Protocol adherence

Informed consent execution

Data entry into EDC systems

Adverse event reporting

Educación

Relevant medical or scientific degree

Descripción del empleo

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.