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Clinical Trials Coordinator, Hem/Onc Research

Work Schedule/Days:  Day / Monday - Friday
Employment Type:  Full-Time
Location:  Children's at Houston Mill 
Requisition #:  34238

 

JOB SUMMARY

Coordinates the care of patients and families enrolled in clinical research trials within accepted practices, policies, and philosophy of Children's Healthcare of Atlanta. Coordinates investigator-initiated and other clinical trials, including communication, regulatory, and research aspects. Summarizes study accrual, toxicities, and other data to ensure appropriate documentation onsite and by participating outside institutions. Acts as liaison between the Data and Safety Monitoring Board and Principal Investigators to ensure that studies are regulated and reviewed appropriately for the program. Proactively supports efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta.

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*
  • 3 years of clinical experience with knowledge about the conduct of clinical trials, research principles, and methodologies/study design
  • 2 years of experience in managing complex projects
PREFERRED QUALIFICATIONS*
  • Master’s degree in Business Administration, Healthcare Administration, or a scientific field
  • Experience in creating and negotiating study budgets and contracts
KNOWLEDGE SKILLS & ABILITIES*
  • Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
  • Self-directed and motivated to work independently toward short- and long-term goals 
  • Good communication, organization, and interpersonal skills
JOB RESPONSIBILITIES*
  1. Provides leadership and training for all multi-centered clinical research activities.
  2. Trains participating sites on all activities related to the research project such as eligibility criteria, enrollment instructions, reporting requirements, and monitoring plans.
  3. Completes regulatory site accreditation and audit process of participating sites.
  4. Oversees participating institutions to ensure that research and protocol activities comply with organizational guidelines and regulatory standards for multi-centered studies.
  5. Develops policies and procedures for the management of multi-centered studies.
  6. Develops educational in-services for multi-centered trials.
  7. Ensures all reporting requirements are met at participating sites.
  8. Serves as a resource for facilitating grants, contracts, and financial tasks for multi-centered clinical research projects.
  9. Oversees the maintenance of sites’ regulatory binders.
  10. Oversees the contracts for participating sites and payment to sites for study start-up, patient enrollment, and other study needs.
  11. Assists in the study design and implementation of new studies.
  12. Provides training and assistance for research protocol development and conduct.
  13. Participates in the development of databases to use as the coordinating center.
  14. Assists in the development of protocols and case report forms.
  15. Confirms patient eligibility from participating sites.
  16. Develops and communicates project status reports and basic demographic and descriptive statistical information to multi-centered trials.
  17. Provides leadership for data and safety monitoring.
  18. Works with study teams to ensure decisions are being met regarding amendments, dose escalation or de-escalation, suspensions/closures, and notification to regulatory agencies and sponsors.
  19. Requests unscheduled meetings of the Data and Safety Monitoring Board when unforeseen circumstances arise.
  20. Notifies the Data and Safety Monitoring Board chairperson of unexpected serious adverse drug reactions or serious adverse events.
  21. Provides coordination of research studies as needed.
  22. Creates and upkeeps lay and web summaries and develops eligibility checklists and specimen summary sheets for assigned studies.
  23. Develops study documents for assigned studies based on protocol and study process.
  24. Develops educational in-services for Children's Healthcare of Atlanta staff for assigned studies.
  25. Develops, maintains, utilizes, and updates protocols, data collection tools, spreadsheets, and databases for assigned studies.
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 - Occasionally (activity or condition exists up to 1/3 of time)
Sitting - Frequently (activity or condition exists from 1/3 to 2/3 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*
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:  1547 Clifton Road NE, Atlanta, GA  30322
Function:  Research - Research


Nearest Major Market: Atlanta

Job Segment: Clinic, Clinical Research, Medical Research, Patient Care, Pediatric, Healthcare