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Title:  Senior Research Coordinator

Division:  Pediatrics
Schedule:  Monday - Friday, 8:00 a.m. - 5:00 p.m.
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $50,251 - $65,329
FLSA Status:  Exempt
Requisition ID:  6275

Summary

The Senior Clinical Research Coordinator provides direct management to fast-paced and detailed therapeutic/interventional drug and device clinical research trials at BCM and Texas Children's Hospital, across a variety of disease areas.  The studies focus rare monogenetic disorders of neurostransmitter synthesis in young children. The coordinator will develop, implement, and coordinate clinical research and logistical procedures for the successful management of clinical trials. Will perform clinical research duties requiring analysis, sound judgment, critical thinking skills, and a high level of knowledge of study specific protocols. Will also work independently with minimal general guidance.  

Job Duties

  • Coordinates multiple research studies with multiple PIs, ability to administer study activities occurring at multiple locations
  • Be proactive and interface with multiple departments across the College and outside of the organization 
  • Manages (clinically and administratively) one or more complex or servilely complex clinical trials
  • Adheres to Baylor College of Medicine, Texas Children’s Hospital and Clinical Research SOPs
  • Adheres to FDA Good Clinical Practices outlining the standard for design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies
  • Verifies eligibility of patients for enrollment in studies based on complex 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
  • Trains and assists lower level clinical research staff with research functions as needed
  • Works directly with high acuity, therapeutic, intervention studies involving investigational devices, spinal infusion and gene therapy

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

  • Clinical trial drug and/or device experience
  • Therapeutic clinical research study experience
  • ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification
  • EPIC experience
  • Must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information

 

 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 6275

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