Clinical Research Quality Assurance & Improvement Specialist

Brown Medicine•Cranston, RI

1d•$71,136 - $117,354•Onsite

About The Position

SUMMARY: The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to 1) analyze and interpret applicable regulations, 2) develop/revise institutional policies and procedures, 3) audit the conduct of human subjects research (biomedical, social &behavioral) and research oversight programs, 4) assess compliance with all applicable regulations, guidance’s, and policies and procedures, 5) identify areas of risk, and 6) oversee the development and implementation of corrective and preventive action plans. Ensures adherence to the standards for the responsible conduct of research and compliance. Assists with preparation for external quality reviews and regulatory audits. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: · Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH -GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures and protect human research participants. · Provides current and accurate compliance information and resources to the research community. · Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance. · Evaluates compliance by planning and performing monitoring for investigator-initiated trials, in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP). · Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution. · Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn. · Exercises appropriate judgment in evaluating audit findings, develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner. · Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner. Collects data on audit findings, prepares comprehensive reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives. · Presents data, trends, and risk assessments to Brown University Health Office of Cancer Research (LOCR) Quality Committee · Works with LOCR Leadership to develop and deliver educational offerings driven by audit findings (e.g. forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators, research staff and other members of the Brown University Health Cancer Institute to promote the responsible conduct of research and assists with site or study-specific self-assessments. · Investigates compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings. · Assists in the management of external audits by regulatory agencies or business partners. · Provides information and services to help research with FDA inspection readiness. · Other job functions as assigned. ssPerforms other duties as assigned. s

Requirements

Bachelor's degree in a healthcare related field required. Nursing degree preferred.
Certification or eligibility to sit for Certification Exam in relevant area (i.e., Certified IRB Professional (PRIM& R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.).
Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subject’s research (ICH-GCP, OHRP, FDA regulations).
A minimum of 5 years substantive experience with Phase I though Phase III trials at the Clinical Research Coordinator or Research Nurse. Training or leadership experience preferred.
Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures.
Excellent organizational and analytical skills: ability to apply presentation and training skills.
Ability to perform multiple tasks with a high level of accuracy and attention to detail.
Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC).

Responsibilities

Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH -GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures and protect human research participants.
Provides current and accurate compliance information and resources to the research community.
Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.
Evaluates compliance by planning and performing monitoring for investigator-initiated trials, in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP).
Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution.
Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn.
Exercises appropriate judgment in evaluating audit findings, develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner.
Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner. Collects data on audit findings, prepares comprehensive reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives.
Presents data, trends, and risk assessments to Brown University Health Office of Cancer Research (LOCR) Quality Committee
Works with LOCR Leadership to develop and deliver educational offerings driven by audit findings (e.g. forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators, research staff and other members of the Brown University Health Cancer Institute to promote the responsible conduct of research and assists with site or study-specific self-assessments.
Investigates compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings.
Assists in the management of external audits by regulatory agencies or business partners.
Provides information and services to help research with FDA inspection readiness.
Other job functions as assigned.
Performs other duties as assigned.