Clinical Trial Support Senior Compliance Coordinator

4 weeks ago


College Station, Texas, United States Texas A&M Health Full time

Job Summary

The Senior Research Compliance Coordinator will provide advanced protocol review and advise investigators, administrators, and others on the requirements of human subjects research, biomedical or behavioral clinical trials, FDA IND/IDE regulations and single IRB processes.

Responsibilities

  • Consults and advises faculty, staff, and students in the preparation and execution of protocols based on thorough knowledge of guidelines, and Federal regulations for human subjects research including clinical trials.
  • Provides advanced pre-review of protocols for compliance including providing recommendations and feedback to supervisor and investigators.
  • Assists investigators with applicable Good Clinical Practice (GCP) and FDA IND/IDE requirements.
  • Performs post-review functions by preparing correspondence, minutes and other reports based upon IRB determinations.
  • Provides support to study teams during clinical trial initiation, close-out, management of investigational products, and internal or external audits.

Requirements

  • Bachelor's degree in applicable field or equivalent combination of education and experience.
  • Four years of experience in industry or federally supported clinical trials, investigator-initiated clinical research, or within a compliance or administrative group focused on regulatory support, clinical operations, or clinical research.

Preferred Qualifications

  • Master's degree in education, business, research, or science related field.
  • Knowledge of biomedical and behavioral research including clinical trials.
  • Knowledge of regulations and ethical principles regarding research including HIPAA, FDA, OHRP and FERPA.

Why Texas A&M University?

We are a prestigious university with strong traditions, Core Values, and a community of caring and collaboration. Amenities associated with a major university, such as sporting and cultural events, state-of-the-art recreation facilities, the Bush Library and Museum, and much more await you. Experience all that a big city has to offer but with a reasonable cost-of-living and no long commutes.

Benefits

  • Competitive salary range: $86,403.12 - $95,043.36.
  • Commensurate with experience.
  • A cover letter and resume are required.
  • Hybrid work option available.


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