Research Nurse II, Research Administration (Galveston)

University of Texas Medical Branch (UTMB)•Galveston, TX

3d•Onsite

About The Position

The Research Nurse II implements research protocols according to study requirements within the University. The role independently and competently performs the nursing process—including assessment, planning, evaluation, and intervention—safeguards study participants’ rights and well-being, and provides operational and administrative support for clinical research activities. The position coordinates clinical research, recruits and evaluates study participants, conducts studies according to protocol, and completes required case report forms and documentation. It educates participants about studies and helps ensure studies comply with FDA and other regulatory guidelines. Duties may also include supporting study start-up and approvals, assisting with informed consent, conducting nursing assessments, educating staff and participants, coordinating with study monitors and other stakeholders, and managing study drugs, supplies, equipment, and specimens. The work takes place in a comfortable indoor environment, though noise, odors, cramped spaces, or fumes may sometimes cause discomfort. Moderate to extreme physical effort may be required, including walking, standing, and lifting; occasional lifting may involve heavy or awkward items exceeding 50 pounds. The role requires adequate vision, hearing, speech, and sense of touch, as well as focused attention and alertness. Exposure to occupational hazards such as communicable diseases, radiation, chemotherapeutic agents, or disoriented or combative patients may occur. Alternate shifts or on-call status may be required.

Requirements

Registered Nurse.
Two years of professional nursing experience in direct patient care or research in an approved specialty area.
Licensed by the State of Texas to practice as a Registered Nurse.
Basic PC skills, including word processing, report writing, and email.
Good written and verbal English skills.
Developing good organizational and time-management skills.
Ability to meet the position’s physical, sensory, attention, and alertness demands.

Nice To Haves

Spanish language skills may be a plus.

Responsibilities

Coordinate the clinical research process.
Recruit, screen, enroll, and evaluate patients participating in studies.
Conduct studies according to protocol and complete case report forms.
Educate study participants and ensure clinical studies follow FDA and other regulatory-agency guidelines.
Obtain vital signs, perform phlebotomy, monitor participant laboratory results, and maintain temperature and quality-control logs as required by protocol.
Serve as a liaison among patients, the principal investigator, sponsors, and other health professionals, communicating information about patient needs or changes.
May assist with developing clinical trial agreements and responding to IRB stipulations to obtain final approval; document IRB and contract approval.
May plan and design protocol source documents and coordinate study initiation.
May organize and facilitate the principal investigator’s process for obtaining informed consent and document it appropriately.
Complete initial patient assessments using interview, observation, and examination.
Perform nursing assessments of participants, including physical, pathophysiological, psychosocial, cultural, spiritual, learning-needs, and age-appropriate assessments.
May conduct in-service education for floor nurses and physicians and serve as a resource to staff.
Identify health-promotion and patient and family education needs related to treatment and follow-up in clinical research.
Complete accurate and concise documentation in participant records and other protocol source documents and forms, including drug documentation.
Identify relevant data from internal and external sources and maintain productive working relationships with study monitors.
Ensure return of test articles and clinical supplies; reconcile study-drug accountability; assist with processing and shipping laboratory specimens; and maintain supply inventory and equipment.
Adhere to department internal controls.
Attend and participate in campus coordinator workshops.
Prepare for certification examination after requirements are met.
Maintain licensure through continuing education.
Perform related duties as required.