Senior Clinical Research Associate

Smart IMS • San Diego, CA

8d • Onsite

About The Position

As a Senior Clinical Research Associate, you will provide hands-on monitoring and data-readiness support for an active, sponsor-led Phase 1 gene therapy study approaching an interim data freeze. Partners with CTM/COL to ensure site related monitoring activities through close out activities are conducted as per GCP, and regulatory requirements. Will complete monitor trip report review, site audit reports, and monitors on site to assess for quality, GCP and regulatory compliance.

Requirements

• Bachelor's or master's degree in life sciences, nursing, healthcare, or related field preferred
• Equivalent combination of education and relevant clinical research experience considered
• Senior-level independent monitoring-PSV/SIV/IMV/COV
• Veeva Vault proficiency, including eTMF/CTMS and monitoring documentation
• Gene therapy / rare disease clinical trial experience strongly preferred
• Complex early-phase (Phase 1/2) trial experience
• On-site and remote SDV/SDR
• Rapid data-cleaning / database lock or interim freeze support
• EDC proficiency, ideally Medidata Rave
• Regulatory binder / ISF review and reconciliation
• Protocol deviation identification, documentation, and follow-up
• AE/SAE and safety data review/reconciliation
• Source documentation review and ALCOA+/GCP compliance
• Site issue identification, escalation, and follow-through
• Site relationship management, particularly academic/rare-disease sites
• Investigational product / gene therapy administration documentation review
• IRB/IBC and essential document familiarity
• Ability to independently prioritize high-volume outstanding SDV and close monitoring gaps
• Strong written monitoring reports and action-item follow-up
• Ability to travel immediately/frequently for on-site monitoring
• Minimal onboarding required / able to become productive quickly

Nice To Haves

• ACRP or SOCRA certification preferred, but not required

Responsibilities

• Data cleaning and monitoring gene therapy clinical studies for adherence to protocol, ICH/GCP, SOP's and follows Clinical Monitoring Plan, i.e., on site and remote visits, create trip reports in Veeva, monitor metrics of site performance.
• Ensures quality of data generated from clinical sites and assists in resolving subject eligibility/protocol deviations issues and confirms accuracy of clinical data.
• Works closely with CTM/Data Management lead/COL and shall follow up on issues and ensure they are closed within expected timeframe.
• The tracking of essential documents are received /approved & filed for the duration of the study.
• Reviews/approves site ICF's for continuity and follow up with functional leads as appropriate.
• Works with CTM/COL to coordinate activities from third party vendors, monitors metrics and study status (accruals and attrition), query tracking, non-compliance & protocol deviations.
• Perform other work-related duties as assigned i.e., data entry

What This Job Offers

• Career Level: Senior
• Education Level: Associate degree