Summary

We are seeking a dedicated and detail-oriented Research Coordinator III to support our aortic device clinical trials and aortic research to achieve our program research goals and advance cutting-edge technology in clinical practice.

Coordinates day-to-day activities of clinical research protocols which include patient consent, enrollment, data entry into the databases, monitoring of research participants, and follow-ups. Ensures accurate data collection, documentation, organization and safety of research participants as per study protocol.

Job Duties

• Create or review research protocols and ensure adherence to regulatory requirements and scientific standards.
• Submit protocols to the Institutional Review Board (IRB) for approval and maintain documentation of IRB approvals and renewals.
• May help prepare budgets for clinical trials and negotiate contracts/agreements with industries, sponsors and/or research collaborators.
• Obtain informed consent from participants after the principal investigator(s) identify potential participants; explain the study process and clinical visits according to the time guidelines as per study protocol. Ensure participants understand the study and address their concerns.
• Retrieve and submit imaging studies to manufacturer.
• Collect participants’ clinical data including preoperative information, operative data, laboratory tests, imaging studies and follow-ups, complete case report forms (CRF) per participant accurately and enter the data into electronic databases.
• Order devices per participant according to PI’s device design. Device ordering and storage involves adhering to regulatory requirements, ensuring accurate documentation, and maintaining high standards of quality and traceability.
• Work closely with clinical staff to get informed of scheduled dates such as participant’s procedure and clinic visits.
• Monitor participant safety and report adverse events to regulatory bodies. Ensure compliance with FDA regulations, Good Clinical Practice (GCP), and study protocols.
• Prepare reports for IRB and other stakeholders including annual DSMB report and FDA report.
• Maintain CRFs and study documents in compliance with GCP guidelines. Prepare for and participate in audits or inspections by regulatory authorities.
• Serve as the point of contact between investigators, industries, and the research team under the supervision of the program director.
• Interact effectively with research team members, related clinical staff, participants, and regulatory bodies.
• Perform other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field.Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree in a related field. No experience required with preferred degree.
• Proficiency in using Microsoft Office Suite.
• Strong organizational and multitasking skills.
• Data management using electronic data capture (EDC) systems.
• ACRP/SOCRA certification.