CTO Clinical Research Nurse - Senior

UT Health San Antonio•San Antonio, TX

About The Position

Under limited supervision, the CTO Clinical Research Nurse (CRN) Senior advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care. CRN’s assist with screening patients, scheduling, and overseeing all on-study requirements. Research Nurses attend study teleconferences with sponsors and clinical research organizations to assure continuity of information. Research Nurses serve as the liaison between the principal investigator and the patient and their family and may review the work of Associate and Intermediate – level CRN’s.

Requirements

Ability to communicate and liaise with research participants, research team members, and other relevant partner/key stakeholders.
Expert ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
Demonstrated ability to monitor important and complex projects concurrently.
Expert Proficiency in clinical skills such as phlebotomy, ECGs, IV insertion, and physical assessments.
Shown ability to follow and adhere to ICH-GCP guidelines for conducting clinical trials.
Expert knowledge of Federal regulations and ethical standards governing human subjects research (e.g., FDA, HIPAA, IRB processes).
Shown ability to assist in the execution of Clinical trial design and the development of methodology, and protocol requirements.
Expert understanding of medical terminology, anatomy, and disease processes relevant to assigned studies.
Expert knowledge of adverse event reporting procedures and documentation standards.
Expert understanding of the principles of informed consent and patient rights.
Ability to use Electronic data capture (EDC) systems and clinical trial management systems (CTMS).
Ability to adhere to Institutional policies and standard operating procedures (SOPs).
Skilled in patient screening, recruitment, and informed consent processes.
Ability to conduct and document study visits according to protocol.
Problem-solving and critical thinking for protocol deviations or logistical challenges.
Collaboration and teamwork in multidisciplinary clinical and research environments.
Ability to communicate and liaise with research participants, research team members, and other relevant partner/key stakeholders.
Demonstrated ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
Demonstrated ability to monitor important and complex projects concurrently.
Associate's Degree is required.
Five (5) years of nursing experience in the designated study area is required.
Active CPR/BLS required.
Texas RN license is required.

Responsibilities

Assists w/ the identification of study objectives and outcome measures while ensuring adherence to all applicable federal, state, institutional, and Mays Cancer Center regulations, policies, and SOPs.
Maintains timely and accurate communication with the interdisciplinary team to support protocol compliance and the efficient conduct of study procedures.
Collaborates with the principal investigator, pharmacy, and other key personnel to ensure proper use and accountability of investigational products.
Provides protocol-specific education and guidance to clinical and research staff.
Helps to coordinate and participate in meetings or teleconferences with sponsors, monitors, and auditors to ensure continuity of study information.
Ensures timely and accurate reporting of serious adverse events, unanticipated problems, deviations, and noncompliance to the IRB and study sponsor.
Assists in developing and implementing corrective and preventive action plans to address deviations, violations, and other compliance issues.
Ensures compliance with institutional policies and IRB requirements for the informed consent process, including use of the most current IRB-approved consent forms.
Collaborates with the physician investigator to conduct, document, and maintain ongoing informed consent and re-consent as required.
Identifies and addresses barriers to effective consent discussions and decision-making (e.g., literacy, language, capacity, distress, time constraints, therapeutic misconception).
Assesses and reinforces patient understanding of study information through ongoing communication and education.
Demonstrates knowledge of and adherence to tiered consent processes for optional correlative studies (e.g., biospecimen, quality of life, and patient-reported outcomes).
Verifies that informed consent is obtained and documented prior to initiating any study-specific procedures.
Collaborates with the investigator to assess and document patient eligibility for clinical trials according to protocol-specified criteria.
Provides education to patients and families regarding study participation, required procedures, and, if applicable, the clinical condition or disease process (directly if an RN, or in coordination with a nurse educator if not).
Coordinates and schedules all protocol-required events and assessments (e.g., pharmacokinetic/pharmacodynamic sampling, imaging, quality-of-life measures, and study visits) to ensure timely completion.
Evaluates and addresses physical, psychosocial, and financial factors that may impact patient adherence to study requirements.
Monitors patient adherence to self-administered study medications, ensuring accurate documentation and proper return of unused agents.
Collaborates with the investigator to assess disease response and determine treatment schedule or dosage modifications, communicating findings to the study team and care providers.
Promotes effective communication between research and clinical staff to ensure continuity of care and evidence-based symptom management in accordance with protocol parameters.
Documents all patient interactions in the legal medical record per institutional and licensure requirements and ensures proper source documentation for research data.
Obtains relevant outside records or laboratory results needed for study documentation and educates research and clinical staff on accurate data recording practices.
Educates the patient and family regarding clinical condition, and/or disease process.
Identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborate with other members of the healthcare team to ensure patient safety.
Involved in the training and education of newer hires of all levels of Clinical Research Coordinators.
Documents all patient encounters in the legal medical record per licensure and institutional requirements.
Obtains documents from outside providers or laboratories that are needed as part of the research data.
Educates other research team members and clinical staff regarding appropriate and accurate source documentation for patients in clinical trials.
Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents.
Maintains the privacy and confidentiality of patients' source documents.
Maintains specified study documents in the Research Coordinator files.
Participates in the development of approved source documents, templates, or forms.
All other duties as assigned.