Research Coordinator II
The Division of Congenital Heart Surgery at Texas Children's Hospital/ Baylor College of Medicine is seeking an experienced Research Coordinator II to support clinical trials, research data registries, and clinical outcomes research in pediatric cardiothoracic surgery. This is an opportunity for a self-motivated, enthusiastic, team-oriented individual to contribute to a growing collaborative research program within the interdisciplinary Texas Children's Heart Center.
The Research Coordinator works closely with CHS faculty, staff, and trainees to coordinate key research support functions, including but not limited to:
- Screening, eligibility review and enrollment of study subjects;
- Obtaining and documenting research informed consent;
- Study visit scheduling and coordination;
- Medical record abstraction, electronic data capture, entry and reporting;
- Tracking and reporting of adverse events;
- Ordering and maintenance of study supplies/equipment;
- Research specimen collection, processing and transport;
- Maintenance of study regulatory binders and patient research charts;
- Preparation and coordination of regulatory submissions;
- Coordination of external monitoring and auditing visits;
- Under supervision, may assist with preparation of study budgets.
The Research Coordinator II serves as the primary site contact for study sponsors and CROs, and is responsible for communicating and troubleshooting potential impacts to research conduct through timely correspondence, and participation in working group and research team meetings. Provides ad hoc support for essential Heart Center Biorepository activities such as patient consent and sample collection, and back-up coordinator coverage for other CHS research staff. Assists with identification, troubleshooting and reporting of regulatory compliance and safety issues, with escalation to research leadership as necessary. Maintains all local, sponsor and federally mandated training requirements for participation in human subjects research.
The ideal candidate will have experience in pediatric clinical outcomes research, medical records, abstraction, electronic data capture, and reporting clinical database/registry management. Working knowledge of clinical research regulatory compliance (ICH/GCP) and record-keeping is essential.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- One year of relevant research experience.
- Excellent organizational and written/oral communication skills.
- Ability to work both independently and as part of a multidisciplinary team.
- Ability to manage multiple projects and commitments simultaneously.
- Ability to prioritize task completion to meet competing deadlines.
- SoCRA or ACRP certification highly desirable.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.