Quality Assurance Nurse - Clinical Trials

Stony Brook University•Town of Brookhaven, NY

21d

About The Position

This position is a very important role within the Cancer Center’s Clinical Trials Department. Under the direction of the Quality Assurance Manager, the Quality Assurance Nurse evaluates patient charts and regulatory documents for compliance and quality assurance. The ideal candidate will be required to both maintain and develop quality assurance processes and procedures, using working knowledge of ICH/GCP requirements along with an understanding for evaluating studies that are Investigator-Initiated, NCI and/or Industry funded. Duties of a Quality Assurance Nurse may include the following but are not limited to: · Demonstrates general knowledge of biological principles and scientific methods. Demonstrates knowledge of regulatory requirements (FDA, IRB, SOPs, GCPs, ICH, etc) by identifying sources of regulatory information, staying current on all new and existing laws, advising staff on regulatory and quality assurance issues, seeking clarification when needed, and conducting training sessions to informs staff of new guidelines/trends. · Under the direction of the QA Manager, and through the internal audit process, the QA Nurse verifies eligibility for enrollment and verifies source documentation for all case report form (CRF) fields and to ensure proper consent documentation. · Under the direction of the QA Manager, the QA nurse will conduct training and education for staff on research compliance, institutional policies, federal guidelines and audit findings as needed. · Under the direction of the QA Manager, the QA nurse will serves as an Auditor on the Data Safety Monitoring Committee (DSMC) and is responsible for monitoring and evaluating the Investigator Initiated Oncology Trials within Stony Brook Cancer Center. · Under the direction of the QA Manager, the QA nurse will work with Investigator Initiated Trials support staff to review Food and Drug Administration applications made on behalf of the University sponsor-investigators for accuracy and compliance to Federal Code of Regulations. · Under the direction of the QA Manager, the QA nurse will participate and assist with preparation for routine audit visits. · Under the direction of the QA Manager, the QA nurse will be responsible for writing audit response letters and developing corrective action plans (CAPA). · Work directly with QA Manager to prepare presentations or reports to communicate findings and recommendations to Stony Brok Cancer Center administration. · Functions autonomously with a high level of attention to detail. · Must be able to exercise judgement and discretion to establish and maintain effective working relationships with others. · Assist in documentation preparation and submission as required from pre and post external inspections (e.g. routine monitoring reports for all studies), including preparing and executing Corrective Action Plans for continuous improvement efforts. · Under the direction of the QA Manager, the QA nurse will review internal databases for data entry accuracy and completeness (e.g. Oncore, Florence, RedCap). · Under the direction of the QA Manager, the QA nurse will assist with training and onboarding for new investigators and research staff. · Under the direction of the QA Manager, the QA nurse will assist with SOP and Work instruction revisions & improvements, including assisting with strategic planning and implementation of continuous improvement efforts. · Under the direction of the QA Manager, the QA nurse will assist with conducting SIVs routine monitoring visiting for multi-institutional sites and monitoring for affiliate sites. · The QA Nurse will be expected to provide backup to the clinical team in the role of a Research Nurse when needed. · Other duties or audits as assigned.

Requirements

Bachelor’s Degree in Nursing
Current and active NYS RN License
At least 5 years of relevant experience working with Clinical Trials
Work Independently with minimum supervision
Good communicator
Knowledge of Computer systems, and databases

Nice To Haves

Advanced degree in nursing
Experience working on Cancer Clinical Trials
Experience working in a QA/QC clinical trials position
Knowledge of regulatory guidance and regulations
Experience with Clinical Trials Monitoring/Auditing

Responsibilities

Demonstrates general knowledge of biological principles and scientific methods.
Demonstrates knowledge of regulatory requirements (FDA, IRB, SOPs, GCPs, ICH, etc) by identifying sources of regulatory information, staying current on all new and existing laws, advising staff on regulatory and quality assurance issues, seeking clarification when needed, and conducting training sessions to informs staff of new guidelines/trends.
Verifies eligibility for enrollment and verifies source documentation for all case report form (CRF) fields and to ensure proper consent documentation.
Conduct training and education for staff on research compliance, institutional policies, federal guidelines and audit findings as needed.
Serves as an Auditor on the Data Safety Monitoring Committee (DSMC) and is responsible for monitoring and evaluating the Investigator Initiated Oncology Trials within Stony Brook Cancer Center.
Works with Investigator Initiated Trials support staff to review Food and Drug Administration applications made on behalf of the University sponsor-investigators for accuracy and compliance to Federal Code of Regulations.
Participates and assists with preparation for routine audit visits.
Responsible for writing audit response letters and developing corrective action plans (CAPA).
Works directly with QA Manager to prepare presentations or reports to communicate findings and recommendations to Stony Brok Cancer Center administration.
Functions autonomously with a high level of attention to detail.
Must be able to exercise judgement and discretion to establish and maintain effective working relationships with others.
Assist in documentation preparation and submission as required from pre and post external inspections (e.g. routine monitoring reports for all studies), including preparing and executing Corrective Action Plans for continuous improvement efforts.
Reviews internal databases for data entry accuracy and completeness (e.g. Oncore, Florence, RedCap).
Assists with training and onboarding for new investigators and research staff.
Assists with SOP and Work instruction revisions & improvements, including assisting with strategic planning and implementation of continuous improvement efforts.
Assists with conducting SIVs routine monitoring visiting for multi-institutional sites and monitoring for affiliate sites.
Expected to provide backup to the clinical team in the role of a Research Nurse when needed.
Other duties or audits as assigned.