Baylor College of Medicine · 6 days ago
Research Coordinator III - Pediatrics - Center for Research Advancement
Baylor College of Medicine is seeking a Research Coordinator III to manage multiple research studies within the Pediatrics Center for Research Advancement. The role involves coordinating clinical trials, ensuring protocol compliance, and serving as a key contact for sponsors and clinical sites.
EducationHigher EducationPharmaceutical
Responsibilities
Educates research participants about study procedures within the scope of practice
Reviews study protocols with participants and verifies informed consent documentation
Schedules participants for protocol-specific tests and procedures, including laboratory work
Explains study processes and procedures to ensure participant understanding
Dispenses investigational medications in accordance with protocol and institutional guidelines; maintains accountability and shipping logs
Collects, processes, stores, or ships biological specimens per protocol and lab manuals, following IATA guidelines
Coordinates with sponsors, study sites, and internal/external agencies to facilitate study activities
Meets with Principal Investigators and sponsors to lead study qualification and feasibility efforts
Manages pending orders for PI review and sign-off; schedules assessments and performs delegated tasks such as ECGs and lab collections
Audits and reviews protocol documents, including informed consent forms
Generates reports and presents data analyses to stakeholders
Implements protocol amendments based on sponsor or site feedback
Submits serious adverse event (SAE) reports to IRBs, federal agencies, and sponsors
Adheres to FDA Good Clinical Practices and institutional SOPs (Baylor College of Medicine, Texas Children's Hospital)
Assists Principal Investigators in collecting and recording data from protocol-related procedures (e.g., surgery, imaging)
Collaborates with physicians, mid-level providers, research nurses, and data managers to document patient care
Gathers patient information via interviews, questionnaires, and chart reviews; enters data into databases or case report forms
Maintains regulatory documentation and study records to ensure compliance with FDA and other regulatory bodies
Prepares documentation for initial and continuing IRB approval
Develops and implements study materials, including Manuals of Operations, SOPs, and study orders
Audits study compliance, generates reports, and presents findings
Interviews, screens, and recruits participants for study enrollment
Educates participants on study procedures and expectations
Conducts informed consent for non-interventional studies after verifying eligibility based on protocol criteria
May assist with ordering supplies and equipment necessary for study execution
Performs other job duties as assigned
Qualification
Required
Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement
Two years of relevant experience
Solid understanding of FDA Good Clinical Practices
Ability to read, analyze, and interpret complex clinical and regulatory information
Ability to manage either the key aspects of large clinical trials or all components of smaller studies
High level of competence and professionalism in performing all core functions of clinical research coordination
Ability to work independently with minimal supervision
Preferred
Bilingual in Spanish
Clinical research experience
Company
Baylor College of Medicine
Baylor College of Medicine, located in the Texas Medical Center, is a health sciences university located in Houston, Texas
Funding
Current Stage
Late StageTotal Funding
$10.85MKey Investors
National Human Genome Research InstituteNational Heart, Lung and Blood InstituteCancer Prevention and Research Institute of Texas
2024-12-05Grant· $3.5M
2024-09-26Grant
2024-09-19Grant
Leadership Team
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