Job Title & Specialty Area: Clinical Research Coordinator Neuro Oncology
Department: Clinical Research
Location: Dallas
Shift: Day, Mon - Fri
Job Type: On-Site
Why Children’s Health?
At Children’s Health, our mission is to Make Life Better for Children, and we recognize that their health plays a crucial role in achieving this goal.
Through our cutting-edge treatments and affiliation with UT Southwestern, we strive to deliver an extraordinary patient and family experience, ensuring that every moment, big or small, contributes to their overall well-being.
Our dedication to promoting children’s health extends beyond our organization and encompasses the broader community. Together, we can make a significant difference in the lives of children and contribute to a brighter and healthier future for all.

SUMMARY:

The Clinical Research Coordinator may coordinate device and drug treatment research trials, as well as observational studies conducted at Children’s Medical Center, including but not limited to study set-up, implementation, fiscal monitoring, and data collection/entry. In the Trauma Services Department, may coordinate trauma and emergency services studies, including literature reviews,study development, and assist with data analysis. Usually serves as the Children’s employee managing the coordination of all aspects of the assigned research project(s) at Children’s in support of the Principal Investigator and ensuring compliance with all Children’s policies, state and federal regulations that govern clinical research.

WORK EXPERIENCE

• At least 1 year of related experience Required

EDUCATION

• Four-year Bachelor’s degree or equivalent experience required
• Graduate or professional work or advanced degree; or equivalent experience preferred

• Evaluate patients for inclusion and exclusion criteria on multiple protocols. Consent and enroll subjects on trials as appropriate. Be familiar with treatment and visit schedules for assigned studies. Coordinate/perform scheduling of procedures and treatments and serve as an educational resource for participants regarding study requirements. Be proficient at reviewing medical records to assess patient’s disease status, treatment course, and adverse events. Complete case report forms and submit to sponsor according to deadlines. Participate in long-term follow-up efforts on research participants and submit on-going data. Communicate with pharmacy to ensure investigational drug is ordered per protocol when needed. Clinically licensed coordinators may be responsible for administering study related medications.
• Open and maintain institutional approval for research studies including but not limited to initial Institutional Review Board submissions (creating consent forms, HIPAA forms, project summaries), new research questionnaires, amendments, annual reviews and adverse event reporting. Consult with Children’s Medical Center Research Department to establish coordinator timesheets and service orders, input research orders in EPIC, and provide ongoing assistance with research billing to ensure compliance with applicable laws and institutional policies. Communicate with sponsor to keep all documents updated. Communicate with physicians and clinical staff regarding patient research participation.
• Coordinate sample procurement according to protocol and disease. Maintain samples of fluids and/or tissue in a sterile condition and promptly distribute to local and national clinical and research laboratories. Assist in labeling and storing of blood, urine and other specimens for analysis. Collect, correlate and file patient records and laboratory data for analysis. Receive reports and facilitate Principal Investigator review of results. Package and ship samples according to local and federal IATA guidelines. Reconcile shipment billing.
• Specific only for positions in Trauma Services: Coordinate with Trauma Registry in obtaining trauma registry reports as needed and approved for research studies. Collect both retrospective and prospective data as required and approved for research studies. Create and maintain study specific databases and data collection tools, and educate others in data collection. Serve as a resource to others conducting trauma/emergency services research at Children’s