Live opening · Posted 5 days ago
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Description supplied by the original job listing.
Pay Range: $65/hr - $70/hr
Location: San Diego, CA – Remote supporting this location
Department: Clinical Operations
Education/Experience:
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
ACRP or SOCRA certification preferred, but not required
Overview:
Seeking an experienced Sr. CRA who can immediately 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.
Major Duties & 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, noncompliance & protocol deviations.
Perform other work-related duties as assigned i.e. data entry
Skills:
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
Work arrangement
Yes
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