CLINICAL RESEARCH NURSE

Duties And Responsibilities

• Planning and implementation of clinical trials, including coordination with study team members, IRB, regulatory bodies, and sponsors.
• Oversight of IRB, regulatory, and FDA submissions, budget preparation, and study management tool development.
• Education and training of other health care professionals on patient participation in clinical trials.
• Screening, recruitment, and enrollment of study participants, procurement of eligibility data and materials, and interfacing with sponsors and investigators.
• Overseeing study lab specimen collection, processing, and shipping, and long-term data collection.
• Participation in Cooperative Group Audits, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits, and department audits.
• Collaboration with the PI in case management of protocol patients, ensuring patient safety and compliance with protocols and regulatory requirements, and patient billing compliance.
• Data management, including data entry and monitoring clinical protocol coordinators for accurate and timely data collection.
• Performing IRB submissions and regulatory management for several research protocols.
• Participation in program research planning, protocol development, data reporting, and grant reporting.
• Engagement in Departmental Process Improvement Activities and National Committees.
• Other duties as assigned.

Qualifications

• Ability to communicate verbally.
• Ability to compile complex reports and develop presentations.
• Ability to compose letters and memorandums.
• Ability to deal calmly and courteously with people.
• Ability to deal with stressful situations.
• Ability to finish tasks in a timely manner.
• Ability to follow oral and written instructions and established procedures.
• Ability to function independently and manage own time and work tasks.
• Ability to lead work teams.
• Ability to maintain accuracy and consistency.
• Ability to maintain confidentiality.
• Ability to maintain office files and follow standard office procedures.
• Ability to negotiate, persuade, and establish direction.
• Ability to organize workflow.
• Ability to plan, coordinate, and develop multiple projects.
• Ability to work as an effective team member.

Minimum Education And/or Work Experience

• Required: Bachelors Degree OR equivalent training acquired via work experience or education.
• Preferred: Bachelors Degree.
• Required: 1-2 years of previous job-related experience.
• Preferred: 3-5 years of previous job-related experience.

Computer Skills

• Proficient in Microsoft Office suite of programs.
• Experience with electronic medical record (EMR), preferably Together Care or EPIC.

Supervisory Responsibilities

• No

Physical Demands

• None

Working Conditions

• None