NSABP Foundation Inc. · 1 month ago
Clinical Research Associate - Level 3
Pittsburgh, PA
Full-time
Hybrid
Mid, Senior LevelNSABP Foundation Inc. is seeking a Clinical Research Associate - Level 3 to support breast and colorectal cancer clinical trial operations. The role includes ensuring accrual to NSABP protocols, data integrity, and regulatory compliance while managing study monitors.
Clinical TrialsHealth CareMedicalNon Profit
Hiring Manager
Lisa Quigley, SHRM-CP
Responsibilities
Actively plans, executes and assesses performance of activities across the life span of study
Ensures timely study start-up. Examples include but are not limited to study timeline start-up development, site selection and Principal Investigator review
Assists with site activation requirements including ICF review, site access to study platforms and other needs as they arise
Facilitates daily or weekly team huddles to assess, plan, review and prioritize activities to ensure timely site activation, accrual, metrics review, compliance with CMP and other study requirements and audit prep
Completes required trainings with appropriate documentation
Develops relationships with site staff and NSABP monitors
Acts as a liaison for NSABP, site staff and external partners
Conducts weekly performance metrics review, identifies gaps and initiates contact with study monitor to review performance as needed. Examples include the number of queries, query resolution, source data verification, protocol deviation reporting and other study specific metrics
Responsible for providing regular metrics assessment to leadership team
Identifies key metrics with poor performance and develops an action plan to remediate the issue
Develops and implements recruitment strategies to ensure accrual targets are met
Ensures site initiation visits, interim monitoring visits and close out visits are compliant with the Clinical Monitoring Plan (CMP)
Reviews and approves itineraries to ensure CMP compliance and associated expense reports
Follows Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines
Develops, writes and implements Study Start-Up Plans, Clinical Monitoring Plans, Roles and Responsibilities grids and other study-specific documents
Collaborates with clinical research organizations and centralized services such as laboratories
Collaborates with data management regarding CRF development and UAT testing
Acts as a resource to sites and investigators
Accompanies study monitors within 3 months of onboarding to confirm that the CMP is implemented accurately, and that PI/site needs are met
Reviews SIV and monitoring reports to ensure expected quality compliance standards are met. These include compliance with CMP, SOPs, WIs and training requirements
Supports study monitors with resolution of significant site issues
Performs other job-related duties as assigned
Qualification
Required
Bachelor's degree required
Prior CRA experience required
Familiarity with electronic TMF, EDC and CTMS systems required
Strong verbal, written and organizational skills with a team-oriented approach required
Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment
Proficiency in Microsoft Office Suite
Preferred
Research certification strongly preferred
Prior experience at CRO strongly preferred
Company
NSABP Foundation Inc.
Partners in Cancer Research… The NSABP Foundation is a not-for-profit academic research organization with a nearly 60-year history of conducting ground-breaking research studies in breast and colorectal cancer.
Founded in 1958
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ronald A. Sugar, Esq. MBA
Chief Financial Officer
Sheila Evans
Chief Operating Officer
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