Clinical Research Specialist

ThedaCare • Appleton, WI

1d • Onsite

About The Position

The Clinical Research Specialist works independently and collaboratively with the research team to coordinate clinical studies. The role includes screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The specialist maintains accurate and timely source documents, collects, documents, enters, and reports data, and responds promptly to sponsor queries. The role also compiles and reports study information, including protocol activity, accrual data, and workload.

Requirements

• High school diploma or GED.
• Certification in a related allied health profession from an appropriately accredited institution.

Responsibilities

• Collaborate with research team members to support clinical research conduct according to protocol and comply with study, sponsor, institutional, state, and federal requirements.
• Maintain accurate source documents related to research procedures.
• Participate in monitoring and auditing activities.
• Assess patient eligibility, support recruitment, conduct trial visits according to protocol, and ensure quality data collection.
• Track adverse events, serious adverse events, protocol deviations, and unanticipated problems (UPIRSO), and provide the principal investigator with input on reporting requirements to the sponsor, institution, and IRB.
• Organize and schedule assessments, tests, and activities to meet research objectives and maintain protocol compliance.
• Collect, record, and enter data into various databases.
• Protect human subjects during clinical trials in accordance with federal regulations and guidance documents.
• Collect, process, ship, and track biological samples according to protocol and within specified timeframes.

Benefits

• Continued opportunities for learning and development.
• Accessible and transparent leadership.
• Commitment to work/life balance.
• Health coaches, relaxation rooms, health-focused apps, and mental health support.
• Minimal or zero copays.
• Team member cost-sharing premiums.
• Daycare.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED