Job link: https://staff-emory.icims.com/jobs/104772/job
The Senior Administrator, Quality Management (QM) in the Winship Cancer Center is responsible in overseeing operations for the CTO Quality Management Department ensuring compliance within the guidelines of the Code of Federal Regulations, International Conference on Harmonization, Winship Comprehensive Cancer Institute Services Standard Operating Procedures (SOPs) and is responsible for all aspects of quality.
Oversees the quality management process to ensure all clinical trials meet consistent standards and ensures a collaborative approach to clinical research.
Provides education related to clinical research for CTO staff, other Winship departments and Emory University.
Implements processes that ensure compliance with requirements for grants, contracts and other outside funding agencies.
Promotes an environment that is conducive to professionalism, ongoing advancement and excellence in practice and identifies opportunities for improvement.
Facilitates and assesses process improvement and standardization within Winship CTO, other Emory University departments and/or affiliates to provide for accurate, efficient, timely and cost-effective clinical research and clinical care practices.
Supports processes to ensure compliance with requirements for grants/contracts and other outside funding.
Participates on various Winship committees and in professional organization.
Encourages and facilitates participation in and original research development for CTO staff.
Responsibilities includes: Responsible for leading Quality Management (QM) activities for assigned clinical trials programs, including the management of audits, quality issues and investigations, and inspections.
Tracking and evaluates monitoring trends for NCTN trials, FDA inspections, sponsor audits and reporting the trends to Winship CTO Leadership.
Partners with Training/Education and DSMC to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards.
Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical trials teams to proactively identify compliance issues/risks and recommend mitigations.
Liaise with various clinical trials monitors, clinical trials study team, auditors, and investigator to promote a high level of quality and consistency across and within programs; develops the risk-based audit and compliance strategy for assigned programs; assists project teams in implementing corrective and preventive actions; and enables teams to be audit/inspection ready, in support of a culture of sustainable compliance.
Manages internal monitoring and external audits of Winship, documents, databases, or internal systems in compliance with GCP and Winship policies and procedures; assesses impact of audit findings on subject safety, data integrity, and business operations.
Conducts audits requiring advanced auditing skills involving technically complex assignments, including audits of high-risk studies/vendors.
Provides expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership.
Develops and implements program-specific risk-based audit and compliance strategy and manages audits of sites, documents, databases, or internal systems in compliance with GCP and Winship policies and procedures.
Assesses impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalates compliance risks to Winship CTO management.
Ensures audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
Facilitates investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitates identification of root cause and development of appropriate corrective and preventive actions; tracks actions and confirm effectiveness; ensures reporting of potential or confirmed violations to regulatory authorities.
Assist with management of GCP health authority inspections; lead clinical development teams in preparation for announced audits/inspections and provide GCP compliance technical support during inspections of investigators.
Facilitates appropriate and timely inspection responses and follow-up actions.
Analyzes, reports, and presents metrics for assigned programs to development teams and Winship CTO management; recommends any required actions and monitor implementation.
Escalates systemic and/or critical problems and recommends appropriate solutions to senior management for immediate and long-term resolution.
Performs additional GCP related activities upon request by Winship CTO management.
Ensures compliance with all applicable regulations and timelines for safety case processing and reporting.
Oversees the CAPA Committee and SOP committee.
Takes on special projects or tasks as required and needed by the Director of the CTO.
Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards.
Seeks out new practice methods and principles, applying them to existing clinical research practices.
Assists the program and offices in complying with all accreditations, legal, regulatory, and safety requirements.
Uses group participation skills when working as a member of a committee or informal work group.
Participates actively and positively on assigned committees.
Accurately identifies opportunities for improvement.
Actively demonstrates facilitative leadership to foster productive teamwork through coaching, mentoring, and counseling.
Other duties as assigned.
Bachelor's degree in a related field (scientific, health related or business administration) and seven year's experience in clinical trials management, sponsored research, or regulatory management, including five years of quality management experience
OR an equivalent combination of education and experience.
Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) certification required within three (3) years of hire.
Master's degree with clinical trials experience and at least 2 years GCP-related Quality Assurance or relevant clinical trials experience in NCTN and industry clinical trials.
Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
Experience as a clinical manager, operations manager, or general manager.
Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members.
Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Experience with good clinical practices and clinical trials development or implementation.
Familiarity with Clinical Trials Monitoring Systems (CTMS).
NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department of work. Emory reserves the right to change remote work status with notice to employee.
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