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Date: Sep 13, 2017

Location: Atlanta, GA, US, 30322

Company: Children's Healthcare of Atlanta

Requisition #:  19033     
Name of Location:   Egleston
Work Schedule:  Day
Employment Type:  Full-Time
Work Days:  Monday - Friday 

JOB SUMMARY

Supports the efforts of investigators initiating clinical research studies by developing and submitting various regulatory and technical documents required in Food and Drug Administration (FDA) submissions, Institutional Review Board submissions and other required documents for the initiation of these projects.  Drafts, reviews, edits and finalizes documents by organizing, analyzing, and interpreting scientific and statistical data.

EDUCATION

  • Bachelor’s degree in a scientific or health-related field

CERTIFICATION SUMMARY

  • Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment
  • Collaborative Institutional Training Initiative (CITI) within 30 days of employment

EXPERIENCE*

  • 5  years of experience in clinical research in a medical/behavioral setting with knowledge about the conduct of clinical trials, research principles, and methodologies/study design
  • 1 year of experience in supervising staff
  • 2 years of experience developing, submitting and executing clinical research projects

PREFERRED QUALIFICATIONS*

  • Master’s degree in scientific or health related field

KNOWLEDGE SKILLS & ABILITIES*

  • Strong writing skills with strong attention to detail
  • Demonstrated ability to manage timelines
  • Self-directed and motivated to work independently toward short- and long-term goals 
  • Thorough understanding of documentation requirements related to IND and IDE submissions

JOB RESPONSIBILITIES*

  1. Prepares Investigative New Drug (IND) submission packets for the FDA that present clinical data objectively and in a clear concise format.
  2. Develops clinical research protocols for investigator-initiated studies.
  3. Develops eIND, Humanitarian Use device (HUDs)  etc. for compassionate use needs
  4. Develops informed consent documents for investigator initiated protocols
  5. Oversees INDs, eINDs, HUDs etc to ensure compliance and timely reporting
  6. Collaborates with physicians to ensure accurate and timely submissions.
  7. Provides coordination of research studies as needed.
  8. Stays abreast of current industry practices and regulatory requirements and guidelines that affect medical writing.

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

Hearing/Speaking - Effective communication with employees, supervisors/managers and staff. Effective communications with patients and visitors, as required.

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)

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

 

 

Location Address:  1405 Clifton Road NE, Atlanta, GA  30322
Function:  Research - Research

 

Overview:

Children’s Healthcare of Atlanta has been 100 percent dedicated 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 622 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 60 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 twelve 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 being Dedicated to All Better and impact the lives of hundreds of thousands of patients and their families each year.


Nearest Major Market: Atlanta

Job Segment: Medical, Pediatric, Medical Research, Clinical Research, Healthcare