We are seeking an experienced professional 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. The candidate will partner with CTM/COL to ensure site‑related monitoring activities through close‑out activities are conducted as per GCP and regulatory requirements. Responsibilities include completing monitor trip report reviews, site audit reports, and on‑site assessments for quality, GCP, and regulatory compliance.
We are seeking an experienced professional 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. The candidate will partner with CTM/COL to ensure site‑related monitoring activities through close‑out activities are conducted as per GCP and regulatory requirements. Responsibilities include completing monitor trip report reviews, site audit reports, and on‑site assessments for quality, GCP, and regulatory compliance.
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.
- Ensure the quality of data generated from clinical sites and assist in resolving subject eligibility/protocol deviations issues and confirm accuracy of clinical data.
- Work closely with CTM/Data Management lead/COL and follow up on issues to ensure they are closed within the expected timeframe.
- Track essential documents are received/approved & filed for the duration of the study.
- Review/approve site ICF's for continuity and follow up with functional leads as appropriate.
- Coordinate activities from third‑party vendors, monitor metrics and study status (accruals and attrition), 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 or related field preferred
- Equivalent combination of education and relevant clinical research experience considered
- ACRP or SOCRA certification preferred, but not required
Join our team in beautiful San Diego, CA, where you can advance your career in a dynamic and innovative environment while enjoying the benefits of living in a vibrant coastal city.
Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Sr. CRA in san diego at Unknown Company
This position is listed as full time and able to be worked remotely.