CTO Clinical Research Nurse - Intermediate

UT Health San Antonio•San Antonio, TX

About The Position

Under general supervision, the CTO Clinical Research Nurse (CRN) Intermediate advocates for patient safety and protocol integrity, follows patient care standards, and communicates effectively to support clinical trials and quality patient care. The nurse assists with patient screening and scheduling and oversees on-study requirements. CRNs attend sponsor and clinical research organization teleconferences to maintain continuity of study information and serve as liaisons between principal investigators and patients and their families. The role supports clinical trial conduct and compliance by coordinating protocol-required procedures, maintaining research and medical documentation, supporting informed consent, monitoring patient safety and adherence, and collaborating with investigators and interdisciplinary teams. The nurse also provides education to patients, families, and staff, and participates in training newer Clinical Research Coordinators.

Requirements

Bachelor's degree required.
Three years of nursing experience in the designated study area required.
Active Texas RN license required.
Active BLS certification required.
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 requirements, 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 follow 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 personnel to ensure proper use and accountability of investigational products.
Provide protocol-specific education and guidance to clinical and research staff.
Coordinate and participate in meetings or teleconferences with sponsors, monitors, and auditors.
Ensure timely and accurate reporting of serious adverse events, unanticipated problems, deviations, and noncompliance to the IRB and study sponsor.
Assist with developing and implementing corrective and preventive action plans to address deviations, violations, and compliance issues.
Ensure that 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 effective 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, such as biospecimen collection, quality-of-life measures, and patient-reported outcomes.
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 and required procedures and, where applicable, the clinical condition or disease process, directly as an RN or in coordination with a nurse educator.
Coordinate and schedule protocol-required events and assessments, including 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 and ensure accurate documentation and return of unused medications.
Collaborate with the investigator to assess disease response and determine treatment schedules 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 maintain appropriate source documentation for research data.
Obtain relevant outside records or laboratory results needed for study documentation and educate staff on accurate data-recording practices.
Educate patients and families about clinical conditions and disease processes.
Identify patients needing additional nursing assessment and management beyond clinical trial requirements and collaborate with the healthcare team to support patient safety.
Participate in training and educating newer hires of all levels of Clinical Research Coordinators.
Perform other duties as assigned.

Benefits

Medical insurance, with employee coverage offered free and options to add family members.
Group term life insurance and basic accidental death and dismemberment insurance provided at no cost, with options to purchase additional coverage.
Three dental insurance plan options for employees and families.
Two vision plan options.
Disability insurance enrollment option.
Flexible spending accounts for qualifying dependent care and health care expenses.
Retirement plan eligibility through TRS or ORP, with voluntary retirement programs also available.
Paid time off of 128 to 208 hours (16 to 26 days) based on years of service, with possible proration in the first year.
Extended Illness Bank accrual of 8 hours per month.
Paid family leave of up to 240 hours (6 weeks) after six months of consecutive employment.
Twelve set paid holidays each year.
Discounts on services, tickets, and gym membership.