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Research Regulatory Coordinator - Houston Mill

Work Schedule/Days:  Day / Monday - Friday
Employment Type:  Full-Time
Location:  Children's at Houston Mill 
Requisition #:  92382

 

JOB SUMMARY

Develops, implements, and supports the regulatory research process by assisting investigators in study design and completion of the regulatory approval process for external and internal clinical research projects and clinical trials specific to the subspecialty of involvement. Functions as a liaison for the Institutional Review Board, study sponsors, and study monitors specific to the subspecialty of involvement. 

EDUCATION

  • Bachelor’s degree in a scientific, health related, or business administration related program or relevant experience in lieu of education. 

CERTIFICATION SUMMARY

  • Basic Life Support (BLS) if role requires patient contact
  • ARUP Handling, Packaging and Shipping Infectious Substances or similar if role requires specimen acquisition
  • Collaborative Institutional Training Initiative (CITI) within 30 days of employment
     

EXPERIENCE*

Three years of research experience. May substitute required experience with equivalent years of education beyond the minimum education requirement.

PREFERRED QUALIFICATIONS*

  • Master's degree in a scientific or health-related field
  • 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
  • Working knowledge of basic statistics

KNOWLEDGE SKILLS & ABILITIES*

  • Must demonstrate a high degree of clerical accuracy with attentiveness to detail and ability to organize data
  • Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to provide education and training
  • Knowledge of medical terminology
  • Self-directed and motivated to work independently toward short- and long-term goals and the ability to exercise independent judgment
  • Good communication, organization, and interpersonal skills
  • Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Access, Excel, and PowerPoint)
  • Must be able to successfully pass the Basic Windows Skill Assessment at 80% or higher rating within 30 days of date of employment

JOB RESPONSIBILITIES*

  1. Manages departmental regulatory aspects for clinical trial and research activities.
  2. Serves as the Institutional Review Board liaison for all regulatory activities within the department.
  3. Compiles and maintains regulatory binders.
  4. Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.
  5. Develops written consent forms for each protocol which conform to federal and institutional guidelines to provide patients, parents, or guardians with detailed summaries to enable informed decisions.
  6. Serves as the site regulatory contact for sponsored projects and assists with all site initiation and monitoring visits.
  7. Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, biosketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.
  8. Develops lay summaries for each protocol which are utilized by the Institutional Review Board in the initial review process.
  9. Develops web summaries for each protocol which are utilized on the clinical trials website for public access to open protocols.
  10. Collaborates with departmental staff and faculty to develop and complete necessary documentation for continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports.
  11. Oversees quality monitoring and reporting activities.
  12. Supports the Manager, Program Research in the day-to-day activities of regulatory safety management for patients enrolled on research protocols.
  13. Collaborates with all departments to ensure research complies with organizational guidelines and regulatory standards.
  14. Assists in formulating departmental policies and guidelines.
  15. Assists in preparation for audit events.
  16. Ensures quality of audits as defined by the area departmental quality standards.
  17. Provides reporting of all regulatory activities to department leadership.
  18. Provides a detailed summary of all new and active protocols to facilitate the Institutional Review Board submission process.
  19. Works collaboratively with faculty and staff on all initial and ongoing protocols, amendments, and Institutional Review Board re-approvals on a monthly basis.

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*

Bending/Stooping - Occasionally (activity or condition exists up to 1/3 of time)
Climbing - Not Present
Lifting - Occasionally (activity or condition exists up to 1/3 of time)
Pushing/Pulling - Not Present
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)
Ability to lift up to 40 lbs independently and greater than 40 lbs with assistance
Hearing/Speaking - Effective communication with employees, supervisors/managers and staff. Effective communications with patients and visitors, as required.

WORKING CONDITIONS*

Some 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, 20 neighborhood locations and a total of 673 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 recognized as a Fortune 100 Best Place to Work, a Best Place for Working Mothers, and as a top employer for diversity and millennials.  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:  1547 Clifton Road NE, Atlanta, GA  30322
Function:  Research - Research


Nearest Major Market: Atlanta

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