CTO Clinical Research Nurse - Intermediate

UT Health San Antonio•San Antonio, TX

20h

About The Position

Under general supervision, the CTO Clinical Research Nurse (CRN) Intermediate advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to support the conduct of clinical trials and quality patient care. The CRN assists with patient screening and scheduling and oversees on-study requirements. The role includes attending study teleconferences with sponsors and clinical research organizations to maintain continuity of information, and serving as a liaison between the principal investigator and patients and their families.

Requirements

Bachelor's degree.
Three years of nursing experience in the designated study area.
Active Texas RN license.
Active BLS certification.
Ability to communicate and liaise with research participants, research team members, and relevant partners and stakeholders.
Ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
Ability to monitor important and complex projects concurrently.
Proficiency in clinical skills such as phlebotomy, ECGs, IV insertion, and physical assessments.
Understanding of ICH-GCP guidelines for conducting clinical trials.
Knowledge of federal regulations and ethical standards governing human subjects research, including FDA, HIPAA, and IRB processes.
Understanding of clinical trial design, methodology, and protocol requirements.
Knowledge of medical terminology, anatomy, and disease processes relevant to assigned studies.
Knowledge of adverse event reporting procedures and documentation standards.
Knowledge of informed consent principles 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.
Skill in patient screening, recruitment, and informed consent processes.
Ability to conduct and document study visits according to protocol.
Problem-solving and critical-thinking skills for protocol deviations or logistical challenges.
Ability to collaborate and work in multidisciplinary clinical and research environments.

Responsibilities

Assist with identifying study objectives and outcome measures while ensuring adherence to applicable federal, state, institutional, and Mays Cancer Center regulations, policies, and SOPs.
Maintain timely and accurate communication with the interdisciplinary team to support protocol compliance and efficient study procedures.
Collaborate with the principal investigator, pharmacy, and other key personnel on proper use and accountability of investigational products.
Provide protocol-specific education and guidance to clinical and research staff.
Help coordinate and participate in sponsor, monitor, and auditor meetings or teleconferences.
Ensure timely and accurate reporting of serious adverse events, unanticipated problems, deviations, and noncompliance to the IRB and study sponsor.
Assist in developing and implementing corrective and preventive action plans for deviations, violations, and other compliance issues.
Ensure informed consent processes comply with institutional policies and IRB requirements, including use of current IRB-approved consent forms.
Collaborate with the physician investigator to conduct, document, and maintain informed consent and re-consent as required.
Identify and address barriers to informed consent discussions and decision-making, including literacy, language, capacity, distress, time constraints, and therapeutic misconception.
Assess and reinforce patient understanding of study information through ongoing communication and education.
Follow tiered consent processes for optional correlative studies, including biospecimen, quality-of-life, and patient-reported outcome studies.
Verify that informed consent is obtained and documented before initiating study-specific procedures.
Collaborate with the investigator to assess and document patient eligibility according to protocol criteria.
Educate patients and families about study participation, required procedures, and, when applicable, the clinical condition or disease process, directly if an RN or in coordination with a nurse educator if not.
Coordinate and schedule protocol-required events and assessments, such as pharmacokinetic/pharmacodynamic sampling, imaging, quality-of-life measures, and study visits.
Evaluate and address physical, psychosocial, and financial factors that may affect patient adherence to study requirements.
Monitor adherence to self-administered study medications, ensuring accurate documentation and return of unused agents.
Collaborate with the investigator to assess disease response and determine treatment schedule or dosage modifications, communicating findings to the study team and care providers.
Promote communication between research and clinical staff to support continuity of care and evidence-based symptom management within protocol parameters.
Document patient interactions in the legal medical record according to institutional and licensure requirements and ensure proper source documentation for research data.
Obtain relevant outside records or laboratory results needed for study documentation and educate research and clinical staff on accurate data recording.
Educate patients and families regarding the clinical condition or disease process.
Identify patients who need additional nursing assessment and management beyond clinical trial requirements, and collaborate with the healthcare team to ensure patient safety.
Participate in training and educating newer hires at all levels of Clinical Research Coordinators.
Perform other duties as assigned.