Clinical Research Nurse, ITS, Clinical Research Center - 73247
Company: The University of Texas Medical Branch
Posted on: November 23, 2020
Registered nurse plus three years of professional nursing
experience in direct patient care or research in approved specialty
Current Texas license to practice professional nursing.
Possesses knowledge and skill necessary to meet nursing standards
for professional practice specified in Texas Nurse Practice Act
without supervision. Provides professional nursing in a research
unit, clinic or hospital setting for individuals involved in
research studies. Safeguards the rights and well-being of study
participants. Ensures general administrative, regulatory and
participant activities are compliant with the study protocol, and
all applicable regulations, policies and procedures.
Commensurate with experience
SPECIFIC JOB RELATED DUTIES
Professional Practice and Performance:
* Assesses, plans, implements, evaluates and documents the daily
care of assigned study participants.
* Performs routine technical procedures/skills according to study
* Uses professional nursing judgement in the administration of
investigational and FDA approved medications, assesses participants
during study visits to determine presence of side effects and
notifies Principal Investigator (PI) of findings.
* Identifies and responds to adverse events requiring medical
invention, implements appropriate care and notifies
* Ensures compliance with study protocol by providing thorough
review and documentation at each study visit to capture protocol
Participant and Family Teaching
* Provides basic participant/family instruction and study specific
teaching to study participants and families.
* Learns to identify unique learning needs based on values,
barriers and readiness to learn.
* Learns to utilize evidence based teaching strategies such as
teach back and return demonstration.
Care Coordination and Delegation
* Learns to plan, coordinate and prioritize participant care
activities, progressing to complex assignments as competencies
* Learns to demonstrate effective time management skills.
* Seeks guidance and appropriate direction when considering
decision about delegation, learning to effectively and respectfully
communicate and delegate.
Ethics, Advocacy and Culturally Congruent Care
* Identifies ethical situations and seeks assistance to
* Learns how to access available resources (ethics consultation)
when ethical issues arise.
* Demonstrates emerging awareness of culturally sensitive care.
Communication and Collaboration
* Supports healthy work environment by demonstrating respectful
verbal and non verbal communication.
* Plans, coordinates and prioritizes participant care activities in
collaboration with inter professional team.
* Identifies a potential professional mentor to develop skills and
* Performs and reports point of care testing (POCT).
* Prioritizes and organizes work to complete required assignments
within a specified timeframe.
* Provides And maintains a clean, safe environment and performs
and/or assists others to perform proper aseptic technique,
isolation procedures and infection control measures.
* Meets periodic UTMB and unit specific compliance requirements for
health screening, training, attendance, safety and CPR.
* Clinical Research Design and Analysis
* Reviews and comprehends protocol, including but not limited to,
study procedures and timelines, inclusion and exclusion criteria
Human Subject Protection and Safety
* Assists the Principal Investigator (PI) and research team to
ensure compliance of clinical research and related activities in
accordance with federal regulations as well as institutional and
sponsoring agency policies and procedures.
* Supports the PI and study team in the implementation of
* Participates in the informed consent process including
discussions with research participants and answering questions
related to the study. Obtains appropriate signatures and dates on
forms and documents process appropriately. Ensures implementation
of amended consent forms and that participants are re consented
* Adheres to all federal regulations and institutional policies and
procedures instituted to safeguard protected health information
* Assists the PI in promptly reporting any adverse events or
unanticipated problems involving risks to research participants or
others according to sponsoring agency and institutional policies
Clinical Study Operations
* Ensures training of individuals involved in the conduct of the
study and maintains documentation of training on an appropriate
* Coordinates and facilitates monitoring and auditing visits.
* Coordinates appropriate and timely reimbursement to participants
(if applicable) in accordance with institutional policies and
* Collaborates with the study team to prepare and submit all IRB
and regulatory submission documents required by protocol.
* Reviews participants for eligibility using protocol specific
inclusion and exclusion criteria, documenting each participant s
eligibility or exclusion.
* Follows institutional processes for laboratory collection and
storage. Assists in processing and shipping laboratory specimens
according to federal regulations and institutional policies and
Contract Management and Billing
* Follows the contract and award terms and conditions as outlined
* Assists with the billing matrix review in the clinical research
management system to facilitate billing of study procedures to the
appropriate research fund.
* Links participants in the electronic medical record to ensure
billing of study procedures to the appropriate funding source.
* Assists with documentation of participant visit/milestone
completion in the clinical trial management system (CTMS).
* Completes study materials, including but not limited to, source
documents, protocol specific flowsheets (PSFs), case report forms
(CRFs), enrollment logs and deviations logs.
* Collects data required by the protocol.
* Assures timely completion of Case Report Forms (CRFs).
* Assists with the organization of study files, including but not
limited to, regulatory binders, study specific source documentation
and other materials.
Communication and Teamwork
* Attends and participates in investigator meetings as required by
Marginal or Periodic Functions:
* Adheres to internal controls and reporting structure.
* Performs related duties as required.
* Moderate to extreme physical effort may be required such as
walking, standing and lifting materials, equipment, objects and/or
* Occasional lifting may be heavy and awkward, over 50 pounds.
* Alternate shift work and/or call status may be required.
* Possible exposure to occupational hazards such as communicable
diseases, radiation, chemotherapeutic agents and disoriented or
* Proficient use of equipment and supplies related to the study,
including mechanical devices for healthcare monitoring of study
EQUAL EMPLOYMENT OPPORTUNITY
UTMB Health strives to provide equal opportunity employment without
regard to race, color, national origin, sex, age, religion,
disability, sexual orientation, gender identity or expression,
genetic information or veteran status. As a VEVRAA Federal
Contractor, UTMB Health takes affirmative action to hire and
advance women, minorities, protected veterans and individuals with
Req id: 73247
Keywords: The University of Texas Medical Branch, Galveston , Clinical Research Nurse, ITS, Clinical Research Center - 73247, Healthcare , Galveston, Texas
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