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 Research Coordinator will work with several of the clinical research teams based on the needs of the department. This Research Coordinator III 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.Job Duties
- Interviews, screen and recruits patients for therapeutic and non-therapeutic studies; performs the subject consent process for biology, procurement and registry studies; explains processes and procedures to educate participant regarding the research study.
- Attends patient visits as required by the protocol.
- Collects patient information through direct patient interviews, questionnaires and chart abstractions; processes documents and enters information into databases or case report forms.
- Assesses patient data for compliance and serious adverse event reporting, and initiate 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.
- May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol and SOPs.
- Maintains study records and regulatory documents for research studies.
- Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol.
- Retrieves and submits test results to appropriate party.
- May correspond with internal and external patients throughout study.
- Orders supplies and equipment.
- 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. creating a Manual of Operations for all protocols, completing a nursing summary; drafting initial nursing orders if the CRC will be used; completing the application to use the CRC unit; preparing the RTSS Service Form which outlines all research sample requirements for the study, etc.)
- Organizes and set ups Site Selection and Site Initiation Visits - working with outside monitors and coordinating schedules with various departments around the institution.
- Responsible for the monitoring and coordination process of study visits of all patients enrolled on therapeutic protocols - includes: attend visits, ensuring that patients have completed required observations, and are adhering to protocol guidelines.
- Consents all eligible patients to open biology/banking and non-therapeutic studies.
- 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..
- Coordinates specimen collection and submission from collaborating institutions and patients.
- Responsible for seamless coordination of site monitoring visits with protocol sponsor, study team, regulatory department, investigational pharmacy, and Principal Investigator.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- Two years of relevant experience.
- Requires interpersonal skills necessary to coordinate research studies.
- Requires effective communication skills, both orally and in writing.
- Requires the ability to understand and implement patient studies and protocols.
- May require experience with computer spreadsheets and database management.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.