Clinical Research Associate - Level 3

PURPOSE

This role supports breast and colorectal cancer clinical trial operations and the primary deliverables of ensuring accrual to NSABP protocols, data integrity and regulatory compliance. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. Leadership responsibilities focus online management of study monitors.

ESSENTIAL FUNCTIONS

• 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.

OTHER RESPONSIBILITIES

• Knowledge of randomized clinical trials principles and procedures.
• Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials.
• Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management.

EXPERIENCE/SKILLS

• Bachelor’s degree required.
• Prior CRA experience required.
• Research certification strongly preferred
• Prior experience at CRO strongly preferred.
• 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

 HYBRID POSITION

• This is a hybrid position consisting of 2 days of remote work (Wednesday and Friday) and 3 days onsite in our office in Pittsburgh, PA (Monday, Tuesday and Thursday).

The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.