Research QA/QI Analyst

2 weeks ago

Atlanta, United States Children's Healthcare of Atlanta Full time

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Work Shift
Day

Work Day(s)
Friday, Monday, Thursday, Tuesday, Wednesday

Shift Start Time
9:00 AM

Shift End Time

5:00 PM

Worker Sub-Type

Regular

Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's.

Job Description

Audits and monitors clinical studies occurring at Children's Healthcare of Atlanta for research compliance. Proactively supports the efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta.

Experience

  • 3 years of experience in facilitating and/or managing clinical research or compliance
Preferred Qualifications
  • Graduate degree and pediatric experience
Education
  • Bachelor's degree in a scientific, health related or business administration program and three years research experience
Certification Summary
  • Certified Clinical Research Professional (CCRP), Certified IRB Professional (CIP), or other comparable Research or Compliance Certification within one year
Knowledge, Skills, and Abilities
  • Knowledge of and experience with regulatory requirements related to pediatric clinical research gained through experience or orientation period after hire or other sufficient regulatory issue experience
  • Ability to communicate effectively with and coordinate efforts of technical and non-technical personnel
  • Knowledge of established techniques, methods, and procedures for indexing, cataloging, referencing, and archiving information both electronically and manually Demonstrated ability to interpret complex information and develop appropriate operational policies based on information
  • Experience in information systems and familiarity with Microsoft operating systems and Microsoft Office
  • Excellent communication and presentation skills, both one-on-one and within small and large groups
Job Responsibilities
  • Provides leadership to ensure compliance in research.
  • Develops and implements research policies and procedures in conjunction with Research Administration leadership based on Children's Healthcare of Atlanta policies and standards and federal and state regulations and guidelines.
  • Provides guidance on federal and state regulations and guidelines.
  • Participates and provides expertise in review of reportable events.
  • Participates in quality and continuous improvement activities to ensure compliance in research.
  • Works in partnership with Institutional Review Board and Research Administration Director to develop a yearly compliance plan that identifies trends and develops actions to remedy noncompliance.
  • Directs and completes monitoring activities.
  • Serves as the liaison for all external study monitors and auditors from sponsoring organizations and state and federal agencies.
  • Develops, implements, and oversees yearly routine monitoring plan in conjunction with Research Administration Leadership.
  • Provides reports to Director of Research Administration on monitoring findings, risk assessments and recommendation for education, and changes to policies and procedures.
  • Provides reports to Chief Compliance Officer and Audit and Compliance Committee on monitoring activities, findings, and educational activities.
  • Provides reports to leadership and other system committees as needed.
  • Provides education to ensure compliance in research.
  • Provides guidance to Research Education Manager in developing education for research staff and investigators, including employee orientation, staff meetings, and targeted education.
  • Provides education in conjunction with audit activities.
  • Participates as research representative on Operational Compliance Committee, including chairing and serving on subcommittees as needed.


Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.

Primary Location Address

1575 Northeast Expy NE

Job Family

Research

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