Research Nurse II, Research Administration (Galveston)

University-of-Texas-Medical-Branc; 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

Research Nurse II, Research Administration (Galveston)

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.

JOB SUMMARY:

Implements research protocols via study requirements within the University, independently and competently performs the nursing process, including assessment, planning, evaluation, and intervention; safeguards the rights and well being of the study participant; and provides general operational support and administrative duties related to clinical activities for research study.

ESSENTIAL JOB FUNCTIONS:

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.

MARGINAL OR PERIODIC JOB FUNCTIONS:

• Performs related duties as required.

EQUIPMENT:

• Competent use of equipment and related supplies; and use of mechanical devices for healthcare monitoring of the patient subject.

WORKING ENVIRONMENT / LOCATION OF POSITION:

• Work environment is located in a comfortable indoor area.
• Conditions such as noise, odors, cramped work space and/or fumes could sometimes cause discomfort.
• Moderate to extreme physical effort may be required such as walking, standing and lifting materials, equipment, objects, and/or patients.
• Occasional lifting may be heavy and awkward, over 50 lbs.
• Vision, hearing, talking, and sense of touch abilities must be adequate to enable one to quickly and accurately perform tasks such as: reading small print, reading from monitoring equipment, defining details, sending and receiving clear and accurate verbal communication.
• Frequent periods of concentrated or focused attention will be needed to interpret visual, auditory, and sensory inputs.
• Alternate shift work and/or on call status may be required.
• Alertness and careful attention to detail will be required to avoid injury.
• May be exposed to such occupational hazards as communicable diseases, radiation, chemotherapeutic agents, and disoriented or combative patients.

OTHER:

• Attends and participates in campus coordinator workshops
• Prepares for certification exam after requirements are met
• Maintains licensures through continuing education (CEU)
• Spanish language skills may be a plus
• Good written and verbal English skills
• Developing good organizational and time management skills

SALARY:

Commensurate with experience.

EQUAL EMPLOYMENT OPPORTUNITY:

UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.