Duties:

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 adherance 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 assits 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 atrition), query tracking, non compliance & 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

Education:

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

Certifications & Licenses:

ACRP Certification SOCRA Certification Pay Range:

$55-65/hr

•based on experience