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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:  6270

Summary

Independently coordinates day to day activities of research protocols with some general guidance on deliverables from the Principal Investigator (PI) and supervising manager, which include screening, enrollment, writing and overseeing regulatory requests (i.e. IRB's – new protocols, renewals, amendments, consent forms, etc.), data entry and monitoring of research participants. Ensures accurate data collection, documentation, organization and safety of research participants. The Research Coordinator will work with clinic patients in a Pediatric Cardiology clinical research area.

Job Duties

  • Serve as lead on assigned projects with background and experience to independently oversee and manage sponsored drug, device and/or investigator initiated clinical trials in Pediatric-Cardiology, with minimal guidance
  • Coordinate clinical research projects, including (but not limited to): corresponding with recruited patients and their families throughout study, screening, scheduling visits, recruitment, sample collection, coordinating sample shipments, regulatory documents (binders, ICF’s, etc.), and IRB’s (local, reliance, commercial)
  • For regulatory compliance/IRB’s: have knowledge of and lead writing, maintenance, preparation and development of IRB protocol documents, consent forms, and regulatory documents
  • Maintain records and regulatory documents and records for research studies between internal and external teams to assure accurate regulatory oversight of clinical trials documents is up to required standards and completed in a timely fashion
  • Collect patient information; process documents and enter information into a database
  • Perform Venipuncture (blood draws), EKGs/ECG’s and obtain vital signs on study participants – on the job training would be provided for these activities
  • Provide reporting of project status and updates for the manager and study PI’s, including long and short-term planning for study timelines
  • Oversee site monitoring visits in collaboration with the study sponsor and institutional offices, and manage all study related documents with the study sponsors, and internal and external stakeholders for the multiple projects assigned
  • Independently manage complex workflows/ project timelines as required per each project to assure meetings are scheduled (internally and externally), samples sent, sponsor data uploaded, PI and manager are up to date on any outstanding items, regulatory items approved, and data collected
  • Explain process and procedures to educate participant regarding the research study
  • Schedule research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol
  • Retrieve and submit test results to appropriate party
  • Order supplies and equipment
  • Validate research data entered in the study database/ registry
  • Work and manage project databases (REDCap, etc), troubleshoot and create new surveys for data collection
  • Upload and retrieve results, patient notes and other relevant study information into Epic and other assigned databases
  • Maintain research data in databases/registry; conduct periodic review of data for accuracy
  • Participate in clinical and research meetings
  • Oversee and mentor work of less experienced staff on the team

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 in a related field and three years of directly related experience
  • Certification: CCRC (Certified Clinical Research Coordinator) or CCRA (Certified Clinical Research Associate)
  • Independent critical thinking and troubleshooting regarding assigned projects.
  • The ideal candidate will be self-motivated and capable of working both independently and as a member of the project team.
  • Experience with REDCap, EPIC, database management, Institutional Review Board (IRB) maintenance, preparation and development, and Good Clinical Practices is a plus.

 

 

 

 

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

 6270

CA; CH