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Title:  Senior Research Coordinator

Division:  Medicine
Schedule:  Monday to Friday, 40 hours/week
Work Location:  Houston, TX
Salary Range:  $51,256 - $70,733
FLSA Status:  Exempt
Requisition ID:  11450

Summary

The Department of Medicine is looking for a Senior Research Coordinator to assist with the management of multiple research projects. The candidate will oversee site operations for multisite and single site studies, ensure protocol compliance, and work to ensure that project milestones are consistently being met. The position requires excellent leadership skills, collaboration, and ability to advance the section's research mission.
 

Job Duties

  • Oversees site operations for multisite and single site studies
  • Performs study coordination/research quality evaluation for each site, including regulatory document control, ensuring protocol compliance and subject safety, monitoring data entry, and ensuring that all sites complete reporting requirements
  • Assists with development and maintenance of electronic data capture (EDC) by creating case report forms (CRF) and performing user acceptance testing (UAT)
  • Manages trial master file (TMF) for study
  • Complete submission of amendments in BRAIN and acts as direct liaison to local Institutional Review Board (IRB) regarding study submissions
  • Assists with the movement of contracts, material transfer agreements (MTA), and data transfer agreements (DTA) through pipeline; ensures that statements of work (SOW) and other information related to study conduct is accurate within contracts
  • Performs site initiation visits and evaluates site readiness for start-up
  • Ensures validity, completeness, and correctness of clinical data collected by sites in collaboration with study PIs, statisticians, and technical team; queries sites on missing/incorrect clinical data
  • Development of protocol amendments, informed consent, manual of operations, and data instruments for amendment packages for consortium
  • Development and maintenance of processing and tracking systems for regulatory documents, subject follow-up outstanding queries, etc.
  • Complete annual progress reports for grant renewal
  • Track milestones and progress of study deliverables
  • Manage membership, meeting minutes, and communications for consortium
  • Assist study PIs with manuscript preparation by proof-reading drafts, ensuring consistency, and working directly with statisticians in order to obtain statistical data
  • Act as liaison between statisticians and clinical investigators; assists with preparing tables and figures for manuscripts, publications, and study reports
  • Approve patient compensation for local study sites
  • Generates reports to be used for invoicing sponsors
  • Implements changes in protocols in order to ensure that study needs are being met effectively
  • Orders research supplies. 
  • Cross-trains to support Regulatory RA (multiple studies):
  • Archives IRB approvals and correspondence.
  • Tracks and maintains updated copies of required individual team member training certificates, CVs, current professional licenses.
  • Processes forms to add/remove study team members.

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.