Contractual Nurse, Clinical Research

UMB’s Center for Vaccine Development and Global Health (CVD) is a leader in vaccine and infectious-disease research with over forty years of life-saving innovation.

About the role

This is a full-time, contractual position within the CVD. The Clinical Research Nurse manages the day-to-day operations of one or more research studies or clinical-trial protocols, ensuring safe, compliant, and high-quality execution.

Responsibilities

• Manage operations of assigned research studies or clinical-trial protocols, including patient instruction, counseling, treatment administration, monitoring, and data analysis.
• Develop and track workflow policies, recruitment strategies, and study progress from initiation through completion.
• Collaborate with Principal Investigators and regulatory staff to prepare new protocol submissions, amendments, and renewals.
• Review proposed protocols for factors such as sample-collection processes, facility location, data-management plans, and potential subject risks.
• Recruit, screen, enroll, and interact with study participants; secure and document informed consent; obtain medical histories.
• Serve as patient advocate throughout the research study or clinical trial.
• Develop and conduct patient and family education.
• Manage patient care in compliance with protocol requirements; monitor subject condition, ensure safety, and maintain confidentiality.
• Identify patient problems and adjust care plans as needed.
• Develop, recommend, and implement clinical-research policies and procedures to meet evolving needs and enforce standards.
• Ensure compliance with Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) requirements.
• Prepare study-related documentation: protocol worksheets, procedural manuals, adverse-event reports, case-report forms, and IRB documents.
• Develop and produce custom and routine reports; conduct quality-assurance audits on data and regulatory documentation.
• Identify protocol problems, inform investigators, and assist in problem resolution.
• Administer treatment procedures or drugs, monitor effects, and conduct subject medical evaluations.
• Obtain biologic tissue and blood samples; collect information via interviews, questionnaires, test results, and charts.
• Manage the collection, database storage, tracking, analysis, and interpretation of complex study data.
• Assist in monitoring study, clinical-trial, or unit budgets and compliance; identify potential research opportunities.
• Assist in writing research grants, publications, study materials, brochures, and correspondence.
• Serve as liaison to other departments, outside organizations, government agencies, and sponsors.
• Attend research-related meetings, conferences, and teleconferences; participate in planning and development activities.
• Provide guidance and direction to clinical-research staff to ensure protocol compliance and clinical objectives.
• Educate and train personnel on compliance and protocol requirements.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree (preference in Nursing or other discipline appropriate to the position).
• Three years of nursing, clinical, or relevant research-specialization experience.
• Current Maryland license in good standing issued by the Maryland Board of Nursing to practice as a registered nurse, or a multistate licensure privilege to practice as a registered nurse in Maryland or the appropriate federal district where research is conducted.
• Certification from the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
• May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials, and/or ionizing radiation.

Skills

• Knowledge of position requirements, applicable regulations, and laws.
• Skill in effective use of applicable technology and systems.
• Ability to communicate effectively both verbally and in writing.
• Ability to work cooperatively with others and independently.
• Ability to demonstrate, understand, apply, and adhere to UMB’s Core Values: Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

Benefits

• Generous leave package: over two weeks of vacation each year, paid holidays, sick time, and community-service time.
• Subsidized comprehensive health insurance and supplemental retirement options.
• Professional learning and development programs.
• Limited tuition remission for employees enrolled at UMB.
• Life insurance and long-term disability.
• Flexible work schedules and teleworking options (if applicable per job).

Pay

$87,000 – $97,000, commensurate with education and experience.