Research Compliance Coordinator - Full-time / Part-time

JOB SUMMARY

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.

EDUCATION

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

CERTIFICATION SUMMARY

• Basic Life Support (BLS) within 30 days of employment if role requires patient contact
• Collaborative Institutional Training Initiative (CITI) within 30 days of employment

EXPERIENCE*

• 3 years of direct research experience as either a study coordinator/nurse or in research administration with knowledge about the conduct of clinical trials, research principles, and methodologies/study design

PREFERRED QUALIFICATIONS*

• NA

KNOWLEDGE SKILLS & ABILITIES*

• In-depth knowledge of state and federal regulatory guidelines related to research
• Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Access, and Excel)
• Must be able to successfully pass the Basic Windows Skill Assessment at 80% or higher rating within 30 days of employment
• Self-directed and motivated to work independently toward short- and long-term goals
• Good communication, organization, and interpersonal skills

JOB RESPONSIBILITIES*

• Monitors internal regulatory files and study patient enrollment according to regulatory guidelines.
• Ensures proper personnel are assigned to study and research compliance training is complete.
• Ensures study recruitment, consents, and other required documents are completed according to the protocol and relevant policies.
• Reviews study correspondence, deviations, reportable events, signed informed consents, assents, Health Insurance Portability and Accountability Act forms, eligibility criteria, treatment plans and adverse event documentation, protocol adherence and appropriate data management, pharmacy records and compliance, and subject file documentation.
• Develops monitoring reports for sponsor investigators.
• Participates in the development of reports for external agencies such as the Food and Drug Administration.
• Participates in the identification of deficiencies and audits trends by assisting with identifying educational needs based on audit and monitor results, assisting with educational materials, working with Research Educator to develop targeted education, and participating in providing education to investigators and staff.
• Assists in the development and review of data and safety monitoring plans by participating in the execution of these plans for assigned studies.
• Assists in the development of corrective action plans for ongoing studies by monitoring progress against plans and providing education to investigators and study teams.
• Assists Manager, Research Compliance in the conduct of audits per yearly audit plan by developing preliminary audit reports, developing and circulating reports, and reporting serious deficiencies as required.
• Assists Manager, Research Compliance in the compilation of data for reports to Children's Healthcare of Atlanta leadership and compliance committees.
• Participates in other duties as assigned.

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 - 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)

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