Research Compliance Coord

Community Health Network•Indianapolis, IN

About The Position

The Research Compliance Coordinator will work under the oversight of the Research Compliance Manager to grow and manage the activities of a sustainable research compliance program, by assisting with the planning, coordination, and continuous process improvement to ensure adherence to internal and external rules and regulations. The coordinator will perform internal audits and monitoring to determine compliance with IRB approved protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. They will also assist with developing training programs consistent with organizational needs and in accordance with the current GCP requirements. Quality Improvement: Key contributor to development and monitoring of safety and quality program. Develop and maintain quality and risk assessment tools and checklists. Work with leadership to provide feedback, deficiencies and common trends identified in audits to ensure timely and effective change to improve overall quality. Internal Audits: Plan, conduct and manage audits of all research activity to evaluate compliance with federal regulation, international guidelines, internal policies, standard operating procedures (SOPs) and all other relevant regulatory requirements. Conduct audit debriefs with project teams and leadership as required. Follow up as appropriate to obtain audit responses. Review responses to audit findings for appropriateness and completeness. Track and conduct periodic follow up on all Corrective Action Preventative Action (CAPA) plans. Collaboration: Collaborate with research teams and principal investigators on responses to audit findings and Corrective Action Preventative Action (CAPA) plans. Assist research teams in the planning and preparation for external audits. Partner with the research compliance staff to foster a culture of compliance and the development and implementation of actions plans in preparation of or in response to external or internal audits. Education/Training: Provide education to study teams as needed regarding compliance and any areas of deficiency. Ensure compliance with all training requirements. Compliance Duties: Evaluate and recommend compliance with standards for the responsible conduct of research, research ethics and integrity, safety and compliance, data security, privacy, confidentiality and protection of human subjects research. Organizes reports to internal stakeholders including Network Compliance department about research program. Individuals may not perform all of these duties, or may perform additional, related duties not listed here.

Requirements

3+ years: Experience in clinical research compliance or auditing
2 year/Associate Degree

Nice To Haves

4 year/Bachelor's Degree
Certified Clinical Research Associate (CCRA-ACRP)

Responsibilities

Key contributor to development and monitoring of safety and quality program.
Develop and maintain quality and risk assessment tools and checklists.
Work with leadership to provide feedback, deficiencies and common trends identified in audits to ensure timely and effective change to improve overall quality.
Plan, conduct and manage audits of all research activity to evaluate compliance with federal regulation, international guidelines, internal policies, standard operating procedures (SOPs) and all other relevant regulatory requirements.
Conduct audit debriefs with project teams and leadership as required.
Follow up as appropriate to obtain audit responses.
Review responses to audit findings for appropriateness and completeness.
Track and conduct periodic follow up on all Corrective Action Preventative Action (CAPA) plans.
Collaborate with research teams and principal investigators on responses to audit findings and Corrective Action Preventative Action (CAPA) plans.
Assist research teams in the planning and preparation for external audits.
Partner with the research compliance staff to foster a culture of compliance and the development and implementation of actions plans in preparation of or in response to external or internal audits.
Provide education to study teams as needed regarding compliance and any areas of deficiency.
Ensure compliance with all training requirements.
Evaluate and recommend compliance with standards for the responsible conduct of research, research ethics and integrity, safety and compliance, data security, privacy, confidentiality and protection of human subjects research.
Organizes reports to internal stakeholders including Network Compliance department about research program.