Summary

The Department of Cardiology at Texas Children's Hospital (TXCH) is seeking a skilled Research Coordinator II. The Research Coordinator II will be responsible for coordinating independently day to day activities of research protocols under the general guidance of the Principal Investigator (PI) and supervising manager, which include (but are not limited to) screening, enrollment, compensation reimbursement, scheduling visits, writing and overseeing regulatory requests (i.e. IRB's, consent forms, etc.), data entry and monitoring of research participants. The candidate will also be responsible for ensuring accurate data collection, documentation, organization and safety of research participants. This position is part of the Pediatric Cardiovascular Clinical Research Core (CVCRC) team and will work collaboratively to ensure successful execution of protocols and clinical trials.

Job Duties

• Interviews, screens and recruits patients for study; explains process and procedures to educate participant regarding the research study.
• Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol. 
• Collects patient information, organizes and maintains study records and processes documents as required by internal and external guidelines.
• Perform Venipuncture (blood draws), EKGs/ECG’s and obtain vital signs on study participants (employees would receive on the job training of phlebotomy and EKGs/ECGs prior to performing on study participants).
• Writes, maintains, prepares and develops IRB protocol documents, consent forms, and regulatory documents.
• Ensures study data accuracy per protocol, regulatory, sponsor and BCM/TCH guidelines.
• Monitor IRB submissions and responds to requests and questions with central and local IRBs.
• Validates research data entered in the study database/ registry.
• Coordinates databases used for projects (REDCap, etc), troubleshoots and creates new surveys for data collection.
• Uploads and retrieves results, patient notes and other relevant study information into Epic and other assigned databases.
• Maintains and enters research data in databases/registry; conducts periodic review of data for accuracy.
• Participates in clinical and research meetings.
• Collects, processes, ships, and maintains paperwork for blood, trial medication and/or biological specimens according to procedures outlined in study protocol.
• Coordinates follow-up interviews and visits with research subjects throughout study.
• Retrieves and submits test results to appropriate party.
• Coordinates multiple clinical trails and sponsored research projects.
• Maintains records and regulatory documents for research studies.
• Orders supplies and equipment.

Minimum Qualifications

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

Preferred Qualifications

• Bachelor’s degree and two years of directly related experience.
• Independent critical thinking and troubleshooting regarding assigned projects.
• Self-motivated and capable of working both independently and as a member of the project team. 
• Experience with REDCap, Epic, Institutional Review Board (IRB) (local and central IRB's such as WIRB, Advarra, etc.), preparation and development, Good Clinical Practice, clinical trails coordination.