Clinical Trial Support Senior Compliance Coordinator

2 months ago

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

We are seeking a highly skilled and experienced Senior Research Compliance Coordinator to join our team at Texas A&M Health. The successful candidate 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.

Key Responsibilities
  • Provide advanced pre-review of protocols for compliance, including providing recommendations and feedback to supervisors and investigators.
  • Assist investigators with applicable Good Clinical Practice (GCP) and FDA IND/IDE requirements.
  • Perform post-review functions by preparing correspondence, minutes, and other reports based upon IRB determinations.
  • Provide support to study teams during clinical trial initiation, close-out, management of investigational products, and internal or external audits.
  • Advises and provides expertise about human subjects research to investigators and committee members related to regulatory and institutional guidelines.
  • Responsible for effective communication and timely responses related to research reviews.
  • Responds to questions regarding the HRPP compliance program.
  • Prepares training materials and conducts regulatory training.
  • Assists investigators and other staff with regulatory files, compliance documentation, and navigating the electronic IRB system to ensure compliance and mitigate problems in the workflow.
  • Works with supervisors in the development or modification of standard operating procedures (SOPs) and office processes.
  • Performs advanced reviews and contributes to updating SOPs.
  • Creates and runs reports as needed.
  • Serves as primary contact for timely responses related to compliance reviews, including issues of non-compliance.
  • Responds to complex questions regarding the compliance program and clinical trial requirements.
  • Manages coordination with other offices and programs providing ancillary reviews.
  • May train other staff and/or student workers on duties and SOPs.
Requirements
  • Bachelor's degree in an 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.
  • Ability to effectively communicate with a broad spectrum of constituents, including faculty members, students, high-level administrators, and IRB staff.
  • Knowledge of word processing, spreadsheet, and database applications.
  • Ability to multitask and work cooperatively with others.
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.
  • Ability to cultivate and maintain professional working relationships with people of varying backgrounds.
Why Texas A&M Health?

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.

  • Competitive salary range: $86,000 - $95,043.36.
  • Comprehensive benefits package, including health and basic life premiums.
  • Annual paid holidays.
  • Up to 12 weeks of paid parental leave.
  • Automatically enrolled in the Teacher Retirement System of Texas.
  • Health and wellness programs.
  • Professional development opportunities.
  • Education assistance for completing a degree while a Texas A&M employee.

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