Sr. Clinic Research QA Monitor

The Senior Clinical Research Quality Assurance Monitor will assess research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidance. Job tasks include ensuring compliance with all Institutional Review Board (IRB), FDA and other study regulatory requirements and completeness of study documentation; reviewing research data with source documentation for accuracy, completeness and integrity; performing investigational product review and accountability. The individual will serve as a regulatory affairs and compliance resource to CETI, CCIR, providing support to junior Quality Assurance coordinators. Under the guidance of the Clinical Research Program Director, the Sr. Clinical Research Quality Coordinator will implement research quality assurance activities, and risk assessment and reduction strategies to ensure research compliance. Activities could include developing and revising monitoring plans, monitoring tools and standard operating procedures; organizing and delivering individual and group education programs; and other activities as assigned. The role requires at least three years substantive experience with Phase I though Phase III trials at the Clinical Research/Quality Assurance Coordinator, Source Data Verification Monitor, Research Compliance Specialist or IRB Reviewer level.

Qualifications – External

Minimum Education

Bachelor’s Degree in scientific discipline or research. (Required)

Master’s Degree (Preferred)

Minimum Work Experience

At least 5 years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject research. (Required)

Previous experience with investigator-initiated or pharma-sponsored clinical trials in one of the following capacities is strongly desired: lead research coordinator, program manager, clinical research monitor, regulatory coordinator or IRB reviewer (Preferred)

Required Certifications

Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP)

Required Skills/Knowledge

·       Analytical, communication and organizational skills generally acquired through completion of a bachelor's degree program and experience reviewing, leading and/or overseeing clinical research.

·       Ability to work well with diverse, goal-driven colleagues to achieve research compliance while minimizing administrative burden.

·       Computer Skills –proficiency with Excel, Word, Outlook, Access, & PowerPoint; along with cloud-based electronic medical record and database programs.

Functional Accountabilities

Responsible Conduct for Research

·       Demonstrates consistent adherence to the standards for responsible conduct of research.

·       Complies with and maintains current documentation of all job-related certifications and training

·       Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance documents.

Quality Assurance Program Monitoring

·       Conducts research compliance audits within established program timeframes, in accordance with institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidance documents.

·       Authors accurate, detailed