Summary

The Senior Research Coordinator clinically and administratively manages multiple studies and complex clinical trials in the Department of Pediatrics, Center for Research Advancement.  Primary responsibilities include patient enrollment, screening, monitoring of research participants, compliance, and reporting to the clinical research sponsor. The Senior Research Coordinator should be able to independently lead the day-to-day operations of a complex clinical research study, and will be responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers.

This position will be working directly with physicians and investigators to treat and follow up on study patients. Must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information. Position at this level operates independently, or with only minimal guidance, the significant and key aspects of a large clinical trial or all aspects of one or more smaller clinical trial or research project. This position is able to execute all the key functions of the clinical research coordination job role, ensuring scientific integrity of data, and protects the rights, safety, and well-being of patients enrolled in clinical trials. Must have the ability to be proactive and effectively communicate with multiple departments across the College and outside of the organization.

The position requires prior clinical research experience and able to work independently with minimal oversight.  

Job Duties

Clinically and administratively manages multiple studies involving rapid scale up and a high volume of patients/participants in a complex clinical trial. 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.

Screening & Enrollment: 20% of Duties

• Interviews, screens and recruits patients for enrollment in studies.
• Explains process and procedures to educate participants regarding the research study.
• Performs the subject consent process of patients after verifying eligibility based on comprehensive inclusion and exclusion criteria outlined in the protocol.

Subject Visits: 30% of Duties

• Conducts subject research study education as required within the scope of practice.
• 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. 

Data Collection & Entry: 20% of Duties

• Responsible for assisting the Principle Investigator with collecting and recording study data related to cauterization procedures, cardiac measurements, and related test and measurement for the study.
• Collaborates with physician, mid-level practitioners, and research nurses and data managers to document patient care.
• Collects patient information through direct patient interviews, questionnaires and chart abstractions; processes documents and enters information into databases or case report forms.
• 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.

Source Document/Document Review & Development: 15% of Duties

• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• Oversees study-related documentation. Reviews protocol documents, including abstracts, text, and informed consent for relevant information.
• Evaluates and analyzes clinical research data as appropriate. Generates reports and presents data analysis.  

Communication with Sponsor/Subjects/PI's: 15% of Duties

• Meets with Principal Investigators and Study Sponsors, operating independently, or with only minimal guidance. 
• Interacts with sponsors and/or coordinating sites as required to facilitate protocol activities and maintains current study documents.
• Submits serious adverse event reporting and follow up as needed.

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.

Adheres to Baylor College of Medicine, Texas Children's Hospital and Clinical Research SOPs

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 a related field or Medical Degree.
• 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.