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Research Study Manager

2 months ago

Tomball, Texas, United States Medix™ Full time

Position Overview:

The selected individual will oversee the management of clinical research protocols from initiation to completion. This position requires effective collaboration with research personnel to gather, organize, and maintain data in accordance with FDA standards, International Council for Harmonization (ICH) guidelines, and Good Clinical Practices (GCP).

Key Responsibilities:

  • Act as the main coordinator or work alongside a research nurse on studies, overseeing source documentation, data collection, data entry, query resolution, financial payment triggers, study closure, and serving as a point of contact with the sponsor/CRO.
  • Assist in identifying suitable clinical trial candidates, evaluating their eligibility, and enrolling them per the study protocol.
  • Manage the schedule of events for clinical trial participants, from initial screening through follow-up, in alignment with the protocol.
  • Gather, verify, organize, and document clinical information and data in electronic data capture (EDC) systems. Extract data from relevant sources to complete the EDC and address queries. Conduct related data activities including EDC tracking, validation review, updates, serious adverse event reconciliation, laboratory data reconciliation, and safety coding.
  • May be involved in regulatory submissions, necessitating a solid understanding of essential documents and Institutional Review Board (IRB) requirements.
  • Engage in site feasibility assessments, site qualification visits, site initiation visits, and research-related meetings.
  • May have responsibilities related to recruiting clinical trials to the site.
  • May include patient-facing duties.