knownwell

Clinical Research

• Serve as a primary point of contact for study participants during on-site visits, providing a welcoming and professional experience.
• Guide participants through study visit procedures, answering questions and ensuring they feel informed and comfortable throughout the process.
• Assist in the informed consent process, ensuring participants understand study expectations, risks, and benefits prior to enrollment.
• Monitor and document participant well-being during visits, escalating any safety concerns to the supervising Coordinator or Investigator promptly.
• Schedule and confirm participant appointments, sending reminders and managing visit logistics to support timely enrollment and retention.
• Perform and document vital signs, including blood pressure, heart rate, temperature, respiratory rate, and weight.
• Conduct electrocardiograms (EKGs) per protocol, ensuring proper lead placement and tracing quality.
• Perform phlebotomy (blood draws) in accordance with study protocols and applicable safety standards.
• Administer and document other protocol-specified assessments as trained and permitted by scope of practice.
• Collect, process, label, and store biological samples (blood, urine, etc.) per study protocol and applicable regulatory requirements.
• Ensure proper cold-chain handling and timely shipment of samples to central labs or sponsors.
• Maintain specimen logs and chain-of-custody documentation accurately.
• Ensure proper disposal of biohazardous materials in compliance with institutional and regulatory standards.
• Accurately enter study data into the clinical trial management system (CTMS) and/or electronic data capture (EDC) systems in a timely manner.
• Complete and maintain source documentation for all participant visits, assessments, and clinical activities.
• Perform basic quality control checks on data entry to ensure accuracy and completeness.
• Flag discrepancies or missing data to the supervising Coordinator for resolution.
• Assist in preparing exam rooms and ensuring all equipment and supplies are ready prior to study visits.
• Support the Coordinator with site initiation, monitoring visits, and closeout activities as directed.
• Maintain adequate inventory of study supplies and assist with the receipt and storage of study materials.
• Support study staff training on visit procedures as needed.

Clinical Research Assistant