Clinical Research Auditor (ICH / GCP)

Clearance Level
None
Category
Quality Assurance
Location
Bethesda, Maryland

REQ#: RQ77211

Travel Required: None
Public Trust: NACLC (T3)
Requisition Type: Regular

GDIT is seeking a Clinical Auditor in support of the the Department of Research Programs (DRP) at the Walter Reed National Military Medical Center’s (WRNMMC). The DRP provides research support services to WRNMMC investigators.

This role would be primarily responsible for auditing clinical research studies to reduce risk to human subject participants, study sponsors, investigators and the command providing post-approval monitoring of clinical research studies from many departments within the WRNMMC hospital. Additional information for the Department of Research Programs: https://walterreed.tricare.mil/About-Us/Department-of-Research-Programs.

Join our team impacting the military medical mission for our active duty military and veterans.

Responsibilities:

  • Assists in executing a comprehensive quality assurance program including consultations, assist visits, random audits, and for-cause audits of ongoing research in the area of human subject protections and compliance in the execution of research.
  • Review and audit proposed and active clinical research studies; interpret research regulations and identify investigator compliance with regulations and requirements relative to clinical settings.
  • Prepares, analyzes, and interprets a variety of documentation and ensures correct application of intended guidance.
  • Track assigned research projects utilizing a risk-based assessment tool to prioritize research studies for in-depth review; Present findings to the Leadership and other participatory entities affected by the studies.
  • Support and maintain the quality internal/external audit and corrective action/preventative action program; completion of internal/external audits according to appropriate regulation or guideline, completion and closure of audit reports and related meetings, maintenance of audit schedule, tracking and closure of audit corrective/preventive actions, trending of audit data.
  • Develop and deliver regulatory/quality training as necessary.
  • Develop reports and documents for internal organizational use and for external agencies; support and maintain regulatory readiness and actively participate in regulator inspections, including acting as audit host for regulatory inspections for the organization when required

QUALIFICATIONS:

Required:

  • Bachelor’s degree
  • 3+ years related experience with clinical auditing experience and be knowledgeable of ICH-GCP and FDA regulations for research studies using human subjects
  • Experience in human subject protections and the following standards/ regulations: Federal Code of Regulations, ICH/GCP (International Conference of Harmonization / Good Clinical Practice), FDA and OHRP (Office of Human Research Protection)
  • Must be a US citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.

Preferred:

  • Advanced degree
  • Experience developing and delivering training programs, specifically regulatory/quality training
  • Experience in human subject protections and the following standards/regulations: DODI (Department of Defense Instructions)

#GDITpriority

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.