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Title:  Research Coordinator III

Division:  Pediatrics
Schedule:  Monday - Friday, 8:00 a.m. - 5:00 p.m.
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $40,785 - $53,000
FLSA Status:  Exempt
Requisition ID:  5537

Summary

Seeking Research Coordinator to manage day-to-day activities of clinical trial studies for RRO-Neurology. The Research Coordinator III will assist with study set-up, implementation, patient recruitment. Will also be responsible for scheduling clinic visits, recording study data, documenting and providing reports to clinical study sponsor. The coordinator will ensure conduct of assigned studies is in accordance with good clinical practice, federal regulations and institutional policies.  Some after hours work may be required occasionally.

Job Duties

  • Manages a clinical trial of a complex rare disease utilizing gene therapy on study population where as they grow older have more complications stemming from the primary condition.
  • Interprets and analyzes safety data and feedback from sponsor/PI for submission to IRB.
  • Manages multiple complex Serious Adverse Events (SAE) and coordinating appropriate safety follow up for subject’s continued management during the clinical trial.
  • Manages and coordinates complex visits for multiple subjects between 2 outside surgical sites.
  • Manages communication between sponsor, CRO, and investigators from both surgical and clinical sites for subject safety and study management.
  • Develops a plan to enroll international patients and manage their visits remotely when required.
  • Develops and executes plan to coordinate complex visits involving multiple departments for study visits.
  • Creates processes for reconsent/immediate risk notifications for multiple subjects as safety issues occur.
  • Conducts research subject recruitment, screening, and enrollment.
  • Conducts subject interviews to evaluate eligibility and continued participation in the study. 
  • Participates in subject consent process.
  • Assists with annual report to FDA for investigator-initiated studies.
  • Travels to other locations for partnering sites at West Campus or University of Houston.
  • Participates in protocol monitoring, audits and follow up in coordination with other research staff.  
  • Prepares study related tools and assist principal investigator in reviewing treatment and visit order sets.
  • Collects, processes and stores or ships blood or biological specimens as outlined per study protocols and associated lab or procedural manuals, in accordance with IATA Guidelines.
  • Participates in RRO- Neurology protocol feasibility assessment and actively participates in protocol meetings including but not limited to investigator and site initiation meetings. Travel to off-site meetings may be required.
     

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

  • Bachelors degree in a scientific or health related field.
  • Clincial Research Coordinator Certification (CCRC).
  • Familiarity with Pediatric Neurology based studies protocols.

 

 

 

 

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

 5537

CA 


Nearest Major Market: Houston