Senior Clinical Research Associate

This is a fully remote position, open to applicants in California.

📋 Description

• Plan, execute, and document both on-site and remote monitoring visits independently, including SQVs, SIVs, IMVs, and COVs

• Implement risk-based monitoring strategies to assess site performance, adherence to protocols, data integrity, subject safety, and completeness of documentation

• Perform source data verification and review

• Oversee daily interactions with investigative sites, manage enrollment, resolve queries, ensure protocol adherence, and monitor study activities and site performance

• Identify, evaluate, document, and escalate monitoring observations, site risks, protocol non-compliance issues, compliance concerns, and data trends

• Generate monitoring visit reports and related follow-up communications

• Track findings and action items until they are resolved

• Maintain essential regulatory and study documentation and ensure readiness for inspections

• Lead site-level activities for study initiation and closure

• Collaborate with Clinical Trial Managers and cross-functional teams to provide monitoring insights and conduct risk assessments

• Mentor junior Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)

• Ensure subject safety by monitoring adverse events and serious adverse events

• Develop and monitor Corrective and Preventive Actions (CAPAs) and assess their effectiveness

• Keep the Investigator Site Files and Trial Master File documentation up to date

• Facilitate training and re-training of site staff on protocols, eClinical systems, specimen handling, and study procedures

⛳️ Requirements

• Bachelor's degree in a life sciences or health-related discipline, or an equivalent combination of education and experience

• 5-8 years of experience in clinical monitoring, including independent on-site and remote monitoring for multi-site studies

• Background in monitoring diagnostics, in vitro diagnostics (IVD), or regulated medical device studies

• Comprehensive understanding of ICH-GCP E6(R2) guidelines and FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812

• Knowledge of risk-based monitoring frameworks and central monitoring methodologies

• Capability to independently manage investigative sites, track enrollment, handle queries, monitor protocol deviations, and escalate risks

• Proficient in EDC systems such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; CTMS; and eTMF platforms including Veeva Vault TMF or Complion

• Skilled in Microsoft Office Suite and Google Workspace

• Experience in preparing monitoring visit reports

• Willingness to travel up to 80% of the time, including short-notice travel

• ACRP CCRA or SoCRA CCRP certification is preferred

• Experience in monitoring infectious disease, microbiology, molecular diagnostics, or related clinical studies is preferred

• Background in mentoring or training junior CRAs is preferred

• Familiarity with LDT and CLIA regulatory frameworks is preferred

• Excellent communication, organizational, time management, problem-solving, judgment, and relationship-building skills

🏝️ Benefits

• Equal employment opportunities

• Disability accommodation for qualified applicants