Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply on company site
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Default4

Clinical Research Compliance Auditor (IRB)

CHRISTUS Health Irving Full-Time
Apply on company site
Description

POSITION SUMMARY

This position reports to the Institutional Official and IRB Director and serves as the primary contact for compliance issues involving human subject research. The position is responsible for the continued development and implementation of a post-IRB approval monitoring program of research studies involving human subjects, research education program, as well as other quality improvement activities. As an auditor, develops and implements the research audit plan to include the performance of audits of research studies to ensure compliance with federal and state law and regulations as well as institutional standard operating procedures relating to the conduct of research studies.



MAJOR RESPONSIBILITIES 

  1. Conducts reviews in response to allegations and findings of noncompliance with federal and state regulations and standard operating procedures as well as sponsor requirements (protocol).
  2. Conduct systematic reviews that evaluate researchers' and their study team's compliance with approved protocols.
  3. Compile reports on audit/monitoring findings. Recommends corrective actions to researchers and the IRBs as required. Reports the findings when appropriate to IRB leadership and others as appropriate.
  4. Receives and handles compliance issues and complaints, and may refer to such items when necessary to the appropriate reporting manager.
  5. Ensures that the implemented research audit program is appropriate in scope, that identified issues are corrected and that all investigators are educated.
  6. Conducts audits to ensure compliance with the study or sponsor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and expectations for data accuracy and completeness. Develops, executes and maintains audit schedules according to the need(s) of the project.
  7. Works with the investigator and study team to identify the root cause and implements corrective and preventive action plans for identified areas of noncompliance.
  8. Assists in the preparation for external audits by regulatory agencies or sponsors. Develops reports for management as requested.
  9. Participates in training on the research process. Interprets regulations and guidance documents governing GCP and applies the interpretation to daily work.
  10. Helps develop and manage research education program.
  11. Reviews adverse events reported by the research teams. Assures that forms are completed and signed by the investigator and that the risk/benefit ratio is not increased. Makes appropriate notifications if the risk is increased.
  12. Maintains current knowledge of applicable federal and state laws, standard operating procedures, GCP, etc.
  13. Assists in the development and implementation of appropriate organizational policies and operating procedures and review of the monthly submission and preparation of IRB agenda (if appropriate).
  14. Attends IRB meetings to ensure compliance and to report any pending compliance issues and/or their remedy.
  15. Assist with all other duties as needed.


Requirements

POSITION QUALIFICATIONS



A. Education/Skills

  • Bachelor's degree; and/or Master's degree preferred.

B. Experience

  • A minimum of five (5) years clinical research experience; with two (2) years of IRB, audit and compliance experience. 


C. Licenses, Registrations, or Certifications

  • Clinical research or compliance certification (CCRP, CCRC, CHRC, CIP, CIM, etc.) preferred and/or obtained within 1 year of employment.
 

Recommended skills

Irb
Good Clinical Practices (Gcp)
Auditing
Clinical Research
Management
Standard Operating Procedure
Apply to this job.
Think you're the perfect candidate?
Apply on company site

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 5000525483006

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.

The two Congregations of the Sisters of Charity of the Incarnate Word in Houston and San Antonio share a common mission of providing the healing ministry of Jesus Christ, which began more than 130 years ago. The shared legacy of the two Congregations dates back to 1866 when three Sisters Religious came from France in response to a call from Catholic Bishop Claude M. Dubuis to come to Texas to help care for the sick and infirm. In the leading port city of Galveston, the Sisters founded the Congregation of the Sisters of Charity of the Incarnate Word and opened the first Catholic hospital in the state. In 1869, three members of the Congregation traveled to San Antonio and established Santa Rosa Hospital. Due to the distance between the cities and the problems of transportation at the time, the Congregation in San Antonio became a separate order with the same name as its founding Congregation.

The Congregations of the Sisters of Charity of the Incarnate Word in San Antonio and the Sisters of Charity of the Incarnate Word in Houston announced in September of 1997 their plans to work together toward combining the health care systems which each sponsors. In July 1998, the two signed a letter of intent, calling for all assets of the Sisters of Charity Health Care System (SCH) and the Incarnate Word Health System (IWHS) to become part of CHRISTUS Health. On February 1, 1999, that dream became a reality and CHRISTUS Health was born.

The Legacy

In 1972 Space Center Memorial Hospital opened to serve the 55,000 community members surrounding NASA Manned Spacecraft Center. The goal of the new hospital was "to return to the people of our country the benefits in the form of health service dividends produced from space exploration."

Unfortunately, the facility was closed in September 1974, only 13 months after it opened, by the Federal Housing Administration because the hospital was behind in mortgage payments. The hospital was unoccupied until the federal government took it over.

In 1981 Congress passed an administration bill, part of President Reagan’s budget-cutting proposals, that closed eight Public Health Service hospitals in the United States. The Houston-based Sisters of Charity of the Incarnate Word Health Care Systems was selected by the federal government to assume control of the U.S. Public Health Service Hospital in Nassau Bay. The government said Sisters of Charity was chosen because of its reputation for providing quality care for its patient population. The Sisters purchased the facility for $1.

On Dec. 9, 1981, CHRISTUS St. John Hospital treated its first patient. The founding sisters of the hospital, Sister Clare Marie, Sister Frances Therese, and Sister Edwin Berry, worked night and day to build St. John Hospital into the quality health care facility it is today. The hospital opened to serve the needs of the community, merchant marines, workers for the Department of Defense as well as Vietnamese and American shrimpers.

In 1982 CHRISTUS St. John Hospital was one of the first hospitals to have a layman, rather than a member of the Congregation, as administrator. Over the years, CHRISTUS St. John Hospital, located across from Johnson Space Center, has been under contract with NASA for provision of the medication kits for the Space Shuttle and for physiological testing for the space program.

A $9 million expansion that was completed in 1989 debuted the concept of LDRP suites in the Center for New Life, enlarged the emergency department and improved diagnostic imaging capabilities.

On Jan. 23, 1998, the hospital unveiled its new street name and address. Hospital Boulevard was renamed St. John Drive in an official proclamation from the mayor. The hospital’s founding sisters were forever memorialized in the new street address, since the "3" in 18300 was chosen to represent the three sisters.

CHRISTUS St. John Hospital has always been committed to the CHRISTUS Health Mission of extending the healing ministry of Jesus Christ through community involvement and programs. The hospital is responsible for establishing Point of Light Clinic, school-based clinics and Project Gabriel in the Dickinson and Nassau Bay areas. CHRISTUS St. John Hospital also received national attention with the development of its parish nurse program.

CHRISTUS St. John Hospital continues to offer quality acute care health services, has added specialties to serve the community, has actively recruited top physicians to fill the needs of Nassau Bay residents, and remains solid in the mission of mercy envisioned by its founding sisters 20 years ago.

View the full profile