Summary

The Pediatrics Department at Texas Children's Hospital Feigin Center is seeking a highly skilled Senior Research Coordinator. A Senior Research Coordinator 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. Responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers.

This position will lead a complex clinical trial.  Applicants should have advance knowledge of clinical research and are able to operate in a highly independent manner with minimal oversight.  Applicants should be able to comfortable communication with internal and external stakeholders (Investigators, Faculty, Sponsors).

Position is supported by Grace Science Foundation and will be collaborating with the Neurology Division within the RRO.

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.
• Collects and records study data related to study procedures such as, but not limited to, catherizations, cardiac measurements, and related test and measurements for the study.
• Performs research related procedures as required; EKGs/ECG's and obtain vital signs on study participants.
• 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

• Master's degree in related field. 
• 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.

Other

• Senior Research Coordinator must have the ability to be proactive and effectively communicate with multiple departments across the College and outside of the organization.
• Must be able to manages a highly demanding complex clinical study involving rapid scale up and a high volume of patients/participants.
• Adheres to Baylor College of Medicine, Texas Children’s Hospital and Clinical Research SOPs.
• Adheres to FDA Good Clinical Practices outlining the standard for safety, design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies.
• Verifies eligibility of patients for enrollment in studies based on comprehensive inclusion and exclusion criteria outlined in the protocol.
• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
• Discusses study protocols with patients and verifies the informed consent documentation.
• Dispenses study medication in a professional and accountable manner following protocol and hospital requirements.
• Ensures that non-serious and serious adverse events are properly documented and reported to internal and external agencies as needed per protocol requirements and federal guidelines.
• Trains lower-level clinical research personnel regarding enrollment, recruitment, EMR transactions, and SOPs.
• Oversees and guides lower-level clinical research personnel regarding study set up and SOPs.
• Participates in study feasibility by completing a comprehensive review of protocol and study logistics such as staffing resources, patient population, and clinical resources needed to correctly conduct study.