Research Coordinator III - Pediatrics
Baylor College of Medicine
Houston, TX
Job posting number: #7184123 (Ref:17303-en_US)
Posted: October 3, 2023
Application Deadline: Open Until Filled
Job Description
Summary
Position coordinates the activities of clinical trial research studies for the Division of Pediatric Critical Care Medicine. Position requires prior clinical research experience. Although this position will be working directly with physicians and investigators, the RC will able to work independently with minimal oversight to oversee the significant and key aspects of a large clinical trial or all aspects of one or more smaller clinical trial or research project. Primary responsibilities include subject screening, enrollment, monitoring of research subject, and reporting to the clinical research sponsor / data coordinating center. Responsible for ensuring accurate data collection, documentation, organization and safety of study subjects. Must have a working knowledge of FDA Good Clinical Practices. Must have the ability to read, analyze, and interpret study information.
Job Duties
- Clinically and administratively manages multiple studies involving rapid scale up and a high volume of patients/participants in large, complex clinical trials.
- During initiation of a study, the PI and RC will work closely together with the main study site to prepare documentation necessary to obtain initial approval of the specific research protocol.
- After initial startup, the study RC will be the main point of contact between institutions. The RC is responsible for maintaining regular contact with the primary site; following up on all regulatory matters and amendments; work with the main site to resolve questions regarding inclusion / exclusion criteria; resolve matters regarding sample processing and shipping; and are responsible for maintaining continuing approval for the specific research protocol.
- The RC, as the study site main point of contact, is required to attend (usually) monthly coordinator calls and bi-yearly meetings. The primary purpose of this participation is to ensure alignment between institutions. // (during initiation of a complex clinical trial, Research Coordinator effort would be approximately 60 -70% of their FTE in these endeavors. The time spent on these efforts tapers off after study initiation to approximately 30%).
- The Research Coordinator must verify eligibility of patients for enrollment in studies based on comprehensive inclusion and exclusion criteria outlined in the protocol.
- The Research Coordinator must have the ability to communicate the study processes and procedures to the study participants. The Research Coordinator is responsible for obtaining informed consent and following correct consent documentation procedures. // 30 %
- The Research Coordinator is responsible for collecting and recording study data. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Submits serious adverse event reporting and follow up as needed. // 40 %
- The Research Coordinator initiates and leads research study education to other hospital personnel (ie Nursing) as required within the scope of practice. The Research Coordinator will work with the Nursing leadership of the appropriate unit to create, provide and present research study educational materials to ensure proper biological sampling techniques as needed.
- 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.
Minimum Qualifications
- Bachelor's degree in a related field.Four years of related experience may substitute for degree requirement.
- Two years of relevant experience.
Preferred Qualifications
- Bachelor's degree or Master's degree in scientific or healthcare related field plus two years of research coordination experience.
- Clinical Research experience.
- Must be willing to work in a fast-paced setting, comfortable working in a team environment, and possess excellent communication skills.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
17303
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.