Clinical Research Nurse

Job Description

The University of Maryland, Baltimore (UMB), Center for Vaccine Development and Global Health (CVD) brings together more than four decades of innovative and life-saving research on vaccines and infectious diseases. CVD is seeking a Clinical Research Nurse at a satellite location in Frederick, Maryland. UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of.

This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 15 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs;

tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.

• Manages operations of one or more pediatric research studies or clinical trial protocols requiring the expertise and care of a Registered Nurse. Instructs and counsels patients in research procedures, administers treatment procedures, monitors patients during procedures, and analyzes patient data. Develops and tracks workflow policies, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
  
  Reviews and recommends proposed research study and clinical trial protocols to evaluate factors such as sample collection process, facility location, data management plans, and potential subject risks.
• Recruits pediatric research and clinical trial subjects. Interacts with subject participants that include eligibility screening, recruitment, and enrollment. Ensures informed consent is properly secured and documented, counseling, and obtaining patient medical history. Serves as a patient advocate throughout the research study or clinical trial. Develops and conducts patient and family education.
• Instructs and counsels patients in research procedures and administers treatment procedures. Manages patient care in compliance with the research study or clinical trial protocol requirements. Monitors subject condition while ensuring safety and maintaining confidentiality. Identifies patient problems and makes adjustments to care plans.
• Develops, recommends, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforce standards. Performs Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) protocol development and ensure compliance of research operations with protocols and all relevant local, federal, and state regulatory and institutional policies.
• Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports. Conducts quality assurance audits on data and regulatory documentation. Identifies protocol problems, informs investigators, and assists in problem resolution efforts. Recommends modifications and adjustments to care plans.
• Administers and implements treatment procedures or drugs, monitors, and studies their effects, and conducts subject medical evaluations. Obtains biologic tissue and blood samples from pediatric research participants as necessary and collects information through interviews, questionnaires, test results, and charts.
• Manages the collection of complex research study or clinical trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data. Prepares study and research related documentation.
• Assists in monitoring study, clinical trial, or unit budget and compliance. May identify potential research study and clinical trial opportunities. Assist in writing research grants, publications in medical and nursing literature, study materials, brochures, and correspondence.
• Serves as a liaison to other departments, outside organizations, government agencies, and sponsor to promote effective and efficient operation and use of resource. Attends research study or clinical trial related meetings, conferences, and teleconferences, as well as participating in any additional planning and development related activities.
• Provides guidance and direction to staff engaged in clinical research or…