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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 - $53,021
FLSA Status:  Exempt
Requisition ID:  6056

Summary

Baylor College of Medicine Department of Pediatrics, Rheumatology Service at Texas Children’s Hospital is seeking a highly motivated, responsible, and organized individual to join a research team focused on childhood arthritis and rheumatic disorders.  The Research Coordinator III, will be responsible for assisting investigators in the overall conduct of clinical trials, coordinating and overseeing day-to-day activities of research protocols for the Childhood Arthritis and Rheumatology Research Alliance (CARRA) study, immune-mediated CNS disorders, along with maintaining regulatory affairs for four national registries, multi-center projects, and all investigator-initiated section studies. This includes screening, enrollment, assisting with questionnaire forms, extracting data from medical records review protocols, review study materials, and ensuring compliance with IRB approved protocols and monitoring of research participants. Will ensure accurate data collection, documentation, organization, and safety of research participants. The Research Coordinator III will require strong organizational skills and will also be the lead, coordinating advocacy related events such as patient/family engagement activities, which include an annual Autoimmune Encephalitis Symposium and a World Encephalitis Day. Future advocacy events will include rare disease events for COPA and systemic JIA. This senior level position requires leadership and mentor skills, as this role will serve as both to junior staff.

Job Duties

Project Management (25%)

  • Maintains regulatory affairs for four national registries, multi-center projects, and all investigator-initiated section studies
  • Maintains records and regulatory documents for all research studies in the section.
  • Monitors IRB submissions and responds to requests and questions with IRB.
  • Interacts with study sponsors.
  • Maintains current regulatory files with sponsors.
  • Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
  • Responsible for quality assurance audits and monitor visits.
  • Maintains records and regulatory documents for all research studies in the section.

Community Outreach (15%)

  • Educates patients, families and clinic staff on research staff and procedures
  • Schedules and coordinates advocacy related events such as patient/family engagement activities, which include an annual Autoimmune Encephalitis Symposium and a World Encephalitis Day. Future advocacy events will include rare disease events for COPA and systemic JIA.
  • Serves as a liaison between the community, PIs and sponsors

Data Management (15%)

  • Responsible for maintaining national registries and sub-projects through a national research group.
  • Collects patient information and enters information into billing database.

Study Management / Clinical and Research Coordinator (45%)

  • Manages daily operations of the Childhood Arthritis and Rheumatology Research Alliance (CARRA study).
  • Interfaces with research subjects with the purpose of recruitment, screening and enrollment.
  • Evaluates subjects for study eligibility and continued participation in the study.
  • Resolves all issues relating to
  • Mentors and trains junior staff

Other duties:

  • Provides leadership for all studies/trials assigned, develop and implements policy and procedures and identifies and implements corrective actions/process when required.
  • Collects patient information; processes documents and enters information into a database.
  • May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
  • Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol.
  • Retrieves and submits test results to appropriate party.
  • May correspond with patient throughout study.
  • Orders supplies and equipment.
  • Manages meetings with investigators across multiple sites
  • Conducts all testing procedures required by study protocol.
  • Evaluates and analyzes clinical research data.
  • Performs literature searches and prepares literature reviews
  • Knowledgeable in documenting study information per protocol.
  • Organizes and conducts meetings and phone conferences regarding new and current protocols.
  • Conducts chart review to identify research participants.
  • Generates data report to determine feasibility for upcoming 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

  • Regulatory/IRB experience
  • Human Subjects Protection/Good Clinical Practice Training

 

 

 

 

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

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