CTO Clinical Research Coordinator - Senior (Mays Cancer Center)

• Independently identifies 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 including review of protocol adherence for lower-level coordinators.
• Coordinates, participates, and assists with leading 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.
• Assists in the review of lower-level Research Coordinators' work.
• 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.
• All other duties as assigned.

Education: Bachelors degree is required.

• Advanced ability to communicate and liaise with research participants, research team members, and other relevant partner/key stakeholders.
• Shown ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
• Advanced ability to monitor important and complex projects concurrently.
• Advanced knowledge of Federal regulations and ethical standards governing human subjects research (e.g., FDA, HIPAA, IRB processes).
• Advanced understanding of Clinical trial design, methodology, and protocol requirements.
• Knowledgeable in Medical terminology, anatomy, and disease processes relevant to assigned studies.
• Advanced knowledge of adverse event reporting procedures and documentation standards.
• Adept understanding of the principles of informed consent and patient rights.
• Proven ability to use Electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Shown ability to adhere to Institutional policies and standard operating procedures (SOPs).
• Skilled at patient screening, recruitment, and informed consent processes.
• Shown ability to conduct and document study visits according to protocol.
• Advanced problem-solving and critical thinking for protocol deviations or logistical challenges.
• Shown collaboration and teamwork in multidisciplinary clinical and research environments.