Clinical Research Nurse II: Study Coordination

Utmb; Galveston (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

UTMB Health in Galveston seeks a Research Nurse II for Research Administration to implement protocols and oversee nursing processes in clinical studies.

The role involves coordinating clinical research, recruiting and monitoring study participants, and ensuring FDA and sponsor guidelines are followed. Requires a Texas RN license and at least two years of direct nursing or research experience.

Qualifications

• Two years of professional nursing experience in direct patient care or research in approved specialty area.
• Licensed by the State of Texas to practice as a Registered Nurse.

Responsibilities

• Coordinates the process of clinical research.
• Recruits, screens, enroll, and evaluate patients who participate in study.
• Conducts studies according to protocol and completes case report forms.
• Educates subjects on the details of the studies and ensures that clinical studies are conducted in accordance with the guidelines of the FDA and other regulating agencies.
• Obtains vital signs and performs phlebotomy; monitors participants labs; maintains temperature and QC logs per protocol compliance.
• Serve as liaison between patients, PI, sponsors, and other health professionals and communicates information concerning patient needs and/or changes.
• May assist with the following: developing the clinical trial agreement; answering IRB stipulations to obtain final approval; documents IRB approval and contract approval; planning and design of source documents for protocol; coordinates study initiation; organizes and facilitates PI in obtaining Informed Consent from study participant and documents appropriately.
• Completion of an initial patient assessment utilizing interview, observation, and examination.
• Performing competent physical, pathophysiological, psychosocial, cultural, spiritual, learning needs, and/or age-appropriate nursing assessment of participants.
• Conducting in-service to floor nurses and physicians; serves as a resource to staff.
• Identifying areas of health promotion and patient and family educational needs regarding treatment and follow-up on specific clinical research.
• Completes accurate and concise documentation on all participant records in addition to other source documentation and forms per protocol including maintaining drug documentation.
• Identifies relevant data from internal and external sources and develops and maintains productive working relationship with study monitor.
• Ensures return of test article / clinical supplies; reconciles study drug accountability; assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment.
• Adheres to internal controls established for the department.

Skills

Direct patient care experience

Education

Texas RN license

Job description

UTMB Health in Galveston seeks a Research Nurse II for Research Administration to implement protocols and oversee nursing processes in clinical studies.

The role involves coordinating clinical research, recruiting and monitoring study participants, and ensuring FDA and sponsor guidelines are followed. Requires a Texas RN license and at least two years of direct nursing or research experience.