SENIOR CLINICAL TRIAL OPERATIONS – ASSOCIATE

Location: Bridgewater, New Jersey | Category: Clinical Development and Operations | Employment: Contract | Worksite: On-Site | Country: United States

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

Qualifications

• 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
• ACRP Certification
• SOCRA Certification

Pay

Pay Range: $55-65/hr *based on experience