Summary

The Texas Children’s Cancer and Hematology Centers (TXCH) Research Coordinator III is responsible for implementing and coordinating the day-to-day activities, which include screening, enrollment and monitoring of research participants, of pediatric protocols on various oncology teams. Ensures accurate data collection, documentation, organization, and safety of research participants. This specific Research Coordinator will work with several of the clinical research teams based on the needs of the department.

This specific RCIII role will serve as the primary research coordinator, as needed, for pediatric therapeutic clinical trials and will oversee the entire process of patients being enrolled on these treatment studies. These critical and complex treatment trials may include multi-site therapeutic protocols, as well as studies involving Cell and Gene therapies.

The ideal candidate is proficient in oncology clinical research, learns quickly, is flexible, adaptable, detail-oriented, and organized while also having excellent computer use, time management, and interpersonal communication skills which will help the individual engage both faculty and staff for specific tasks, as well as, to work independently. 

Job Duties

• Interviews, screens and recruits patients for therapeutic and non-therapeutic studies.
• Collaborates with study team and physicians to assist in determining patient eligibility for research protocols.
• Performs the subject consent process for biology, procurement and registry studies.
• Responsible for the monitoring and coordination process of study visits of all patients enrolled on study including explaining processes and procedures to educate participants regarding the research study, attends visits, ensures that patients have completed required observations, and are adhering to protocol guidelines
• Collects patient information through direct patient interviews, questionnaires and chart abstractions; processes documents and enters information into databases or case report forms.
• Maintains study subject files.
• Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol
• Assesses patient data for compliance and serious adverse event reporting, and initiates expeditious reviews of study data and source documentation with the Principal Investigator as warranted.
• May perform EKGs/ECG’s and obtain vital signs or other biometric information on study participants. Employees may be required to receive on the job training of phlebotomy and EKGs/ECGs prior to performing on study participants.
• May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol and SOPs.
• Completes training sessions with various personnel who will be working on the study (ex. finalizing the nursing in-service, training various teams, etc.).
  • Creates/administers nursing education for new therapeutic protocols prior to their implementation in the outpatient clinic, inpatient 9th floor, and Clinical Research Center (CRC).
  • Coordinates appropriate time for education with the nursing education manager.
• Drafts multiple study documents to initiate the study start up process (ex. creates a Manual of Operations for all protocols, completes a nursing summary; drafts initial nursing orders if the CRC will be used; completes the application to use the CRC unit; prepares the RTSS Service Form which outlines all research sample requirements for the study, etc.).
• Organizes and sets up Site Selection and Site Initiation Visits – working with outside monitors and coordinating schedules with various departments around the institution.
• Accountable for accurate research order entry into Epic Beacon/review of orders with providers to ensure everything has been entered correctly and confirms that they were indeed collected.
• Works directly with multiple departments to coordinate diagnostic procedures (ex. working alongside Cardiology to schedule protocol-specific echocardiograms).
• For studies that involve cell and gene therapies, the RCIII will be responsible for scheduling patients with the apheresis clinic, ensuring all CAGT paperwork is complete, monitoring the cell collection process (ex. updating the team on the apheresis status, plans for catheter removal, etc.) and entering all data into the cell chain and communicating shipping dates with the cell processing team.
• Retrieves and submits test results to appropriate party.
• May correspond with internal and external patients throughout study.
• Orders supplies and equipment.
• Responsible for seamless coordination of Site Monitoring visits with protocol sponsor, study team, regulatory department, investigational pharmacy, and Principal Investigator.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Oncology study experience.
• Experience with Epic EHR.
• Bilingual in Spanish is a plus.