Under direct supervision the Clinical Research Coordinator (CRC) - Associate champions patient safety and protocol integrity while upholding the highest standards of patient care. The CRC communicates effectively to support the successful conduct of clinical trials and ensure quality outcomes. Responsibilities include screening and scheduling patients, coordinating all on-study activities, and maintaining compliance with study requirements.
The CRC also participates in study teleconferences with sponsors and clinical research organizations to promote clear communication and continuity of information. 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.
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. Adheres to the data management plan per Mays Cancer Center SOPs and sponsor data management plan. Assists in troubleshooting data entry issues.
Ensures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner. Ensures that data recorded on the CRFs can be verified within the source documents. Participates in quality control activities to ensure data integrity, including timely responses to database or sponsor queries.
Enters data into electronic data capture for SAEs as appropriate.
Bachelors degree is required. 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. Basic knowledge of Federal regulations and ethical standards governing human subjects research (e.g., FDA, HIPAA, IRB processes). Basic understanding of Clinical trial design, methodology, and protocol requirements.
Knowledgeable in Medical terminology, anatomy, and disease processes relevant to assigned studies. asic knowledge of adverse event reporting procedures and documentation standards. Basic knowledge 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.
Full time