Clinical Research Nurse, Internal Medicine - Oncology and Hematology

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

About The Position

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.

Requirements

Registered nurse plus three years of professional nursing experience in direct patient care or research in approved specialty area.
Current Texas license to practice professional nursing.
Current BLS.

Nice To Haves

ACLS.

Responsibilities

Assesses, plans, implements, evaluates and documents the daily care of assigned study participants.
Performs routine technical procedures/skills according to study protocol.
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 medical/research team.
Ensures compliance with study protocol by providing thorough review and documentation at each study visit to capture protocol requirements.
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.
Learns to plan, coordinate and prioritize participant care activities, progressing to complex assignments as competencies increase.
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.
Identifies ethical situations and seeks assistance to resolve.
Learns how to access available resources (ethics consultation) when ethical issues arise.
Demonstrates emerging awareness of culturally sensitive care.
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 abilities.
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.
Reviews and comprehends protocol, including but not limited to, study procedures and timelines, inclusion and exclusion criteria and confidentiality.
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 recruitment strategies.
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 when appropriate.
Adheres to all federal regulations and institutional policies and procedures instituted to safeguard protected health information (PHI).
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 and procedures.
Ensures training of individuals involved in the conduct of the study and maintains documentation of training on an appropriate log.
Coordinates and facilitates monitoring and auditing visits.
Coordinates appropriate and timely reimbursement to participants (if applicable) in accordance with institutional policies and procedures.
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 procedures.
Follows the contract and award terms and conditions as outlined by management.
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.
Attends and participates in investigator meetings as required by PI.
Adheres to internal controls and reporting structure.
Performs related duties as required.