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Research Compliance Consultant

Location:  Office Park (1711) 
Requisition #:  36893

JOB SUMMARY

Under the general direction of the Chief Compliance Officer, the Research Compliance Consultant oversees and supports Children’s Healthcare of Atlanta research activities to help ensure compliance with regulatory requirements and policies. In collaboration with Research Administration, develops, implements and monitors Research Compliance initiatives and activities. Serves as the Research Compliance Officer.  Researches, analyzes and reports on various regulatory issues that may arise within Children's Healthcare of Atlanta.

EDUCATION

Bachelor’s degree in business, health administration or related field

CERTIFICATION SUMMARY

Certified in Healthcare Research Compliance (CHRC), or obtain within one year of employment

Certified IRB Professional (CIP) or other similar Certification

EXPERIENCE*
  • 5 years of experience in facilitating and managing clinical research compliance
  • Previous Healthcare Experience
  • Experience implementing a healthcare Compliance Program, including leading large-scale initiatives, development of compliance audit plans, and handling confidential investigations
PREFERRED QUALIFICATIONS*
  • Graduate Degree
  • Pediatric experience
KNOWLEDGE SKILLS & ABILITIES*
  1. Extensive knowledge of and experience with regulatory requirements related to research and pediatric clinical research
  2. Experience developing and monitoring Research Compliance Plans, including auditing research studies, policies, and procedures
  3. Demonstrated ability to research, analyze and summarize complex information and develop appropriate guidance based on information
  4. Demonstrated ability to manage large projects; Ability to work independently and prioritize objectives
  5. Ability to effectively interact with leaders, physicians, and staff
  6. Experience in information systems and familiarity with Microsoft operating systems and Microsoft Office
  7. Excellent writing, analytic, and oral communication skills and presentation skills, both one-on-one and within small and large groups
JOB RESPONSIBILITIES*
  1. Leads research compliance initiatives for the System
  2. Develops and implements the annual research compliance plan in partnership with research administration leaders
  3. Develops, implements, and oversees research compliance auditing plan
  4. Oversees the Research Conflict of Interest Committee; Manages the review of conflicts of interest related to research
  5. Performs risk-based compliance reviews, audits and risk assessments at the direction of Leadership
  6. Develops policies and procedures, based on federal and state regulations and guidelines in collaboration with Research Administration
  7. Conducts investigations, including research misconduct
SYSTEM RESPONSIBILITIES*

Safety: Practices proper safety techniques in accordance with hospital and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.

 

Compliance: Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process. Maintains records of compliance activities and reports compliance activities to the Compliance Office.

 

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification.  They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.

PHYSICAL DEMANDS*
Ability to lift up to 15 lbs independently not to exceed 50 lbs without assistance
Bending/Stooping - Occasionally (activity or condition exists up to 1/3 of time)
Climbing - Occasionally (activity or condition exists up to 1/3 of time)
Hearing/Speaking - Effective communication with employees, supervisors/managers and staff. Effective communications with patients and visitors, as required.
Lifting - Occasionally (activity or condition exists up to 1/3 of time)
Pushing/Pulling - Occasionally (activity or condition exists up to 1/3 of time)
Sitting - Constantly (activity or condition exists 2/3 or more of time)
Standing - Occasionally (activity or condition exists up to 1/3 of time)
Walking - Occasionally (activity or condition exists up to 1/3 of time)
WORKING CONDITIONS*
No potential for exposure to blood and body fluids

 

About Us:

Children’s Healthcare of Atlanta has been 100 percent committed to kids for more than 100 years. A not-for-profit organization, Children’s is dedicated to making kids better today and healthier tomorrow.

With 3 hospitals, 27 neighborhood locations and a total of 638 beds, Children’s is the largest healthcare provider for children in Georgia and one of the largest pediatric clinical care providers in the country. Children’s offers access to more than 70 pediatric specialties and programs and is ranked among the top children’s hospitals in the country by U.S. News & World Report.

Children’s has been ranked on Fortune magazine’s list of “100 Best Companies to Work For” for fourteen consecutive years and named one of the “100 Best Companies” by Working Mother magazine. We offer a comprehensive compensation and benefit package that supports our mission, vision and values. We are proud to offer an array of programs and services to our employees that have distinguished us as a best place to work in the country. Connect to our mission of making kids better today and healthier tomorrow. 

Have questions about the recruitment process?  Check out What to Expect.

Address:  1711 Tullie Circle, Atlanta, GA  30329
Function:  Legal/Compliance - Consultant


Nearest Major Market: Atlanta

Job Segment: Clinical Research, Medical Research, Information Systems, Pediatric, Healthcare, Technology