Summary

The Pediatrics Department at Texas Children's Hospital Feigin Center is seeking a highly skilled Senior Research Coordinator. The Senior Research Coordinator is needed in the Research Resources Office to independently lead the day-to-day operations of a complex clinical research study. Primary responsibilities include rapid scale up of patient enrollment activities, screening, monitoring of research participants, and reporting to the clinical research sponsor. This position is also responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers.

Job Duties

• Manages patient enrollment (recruiting, screening, and interviewing) and study consent process of patients into a clinical research study(s).
• Explains the study's processes and procedures to educate the study participants.
• EKGs/ECG's and obtain vital signs on study participants.
• Is responsible for electronic case reporting requirements in accordance with all FDA and clinical trial study requirements.
• Manages and enters study information into CTMS (clinical trial management system) database.
• Communicates with patients and families throughout study.
• Interacts with sponsors and/or coordinating sites as required to facilitate protocol activities and maintains current study documents.
• Collects, processes and stores or ships blood or biological specimens as outlined per study protocols and associated lab or procedural manuals, in accordance with IATA Guidelines.
• Maintains records and regulatory documents and records for the research study.
• Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific study visits for the research protocol.
• Retrieves and submits test results to the appropriate party.
• Schedules and orders study supplies and equipment as necessary.
• Reviews protocol documents, including abstracts, text, and informed consent for relevant information.
• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• Collaborates with physician, mid-level practitioners, and research nurses and data managers to document patient care.
• Conducts subject research study education as required within the scope of practice.
• Submits serious adverse event reporting and follow up as needed.
• Evaluates and analyzes clinical research data as appropriate.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification
• EPIC experience
• Therapeutic clinical research study experience
• Knowledge of FDA Good Clinical Practices