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, such as 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 site relationships, manage enrollment, resolve queries, ensure protocol compliance, and monitor study timelines and performance.

• Identify and record monitoring observations, site risks, protocol deviations, compliance issues, and data patterns; escalate concerns with corrective actions.

• Prepare reports on monitoring visits and related follow-up communications.

• Track findings and action items until resolution and confirm their effectiveness.

• Maintain essential regulatory and study documents for readiness during inspections.

• Lead activities related to site initiation and closure.

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

• Provide mentorship to junior CRAs and CTAs.

• Monitor adverse events and serious adverse events, escalating safety issues as necessary.

• Develop and validate corrective and preventive action plans.

• Maintain documentation for Investigator Site Files and Trial Master File.

• Assist in training and retraining 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 across multiple sites.

• Experience monitoring diagnostics, in vitro diagnostics (IVD), or studies involving regulated medical devices.

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

• Familiarity with risk-based monitoring frameworks and central monitoring methods.

• Capacity to independently manage investigative sites, including tracking enrollment, managing queries, documenting protocol deviations, and escalating site-level risks.

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

• Proficient in Microsoft Office Suite and Google Workspace.

• Experience in preparing high-quality monitoring visit reports.

• Willingness to travel up to 80% of the time, sometimes on short notice.

• ACRP CCRA or SoCRA CCRP certification is preferred.

• Preferred experience in monitoring infectious disease, microbiology, molecular diagnostics, or related clinical studies.

• Preference for experience in mentoring or training junior CRAs.

• Familiarity with LDT and CLIA regulatory frameworks is preferred.

• Strong skills in written and verbal communication, organization, time management, problem-solving, judgment, and relationship building.

🏝️ Benefits

• Commitment to equal employment opportunities and fostering diversity and inclusion.

• Provision of disability accommodations for qualified applicants.