Senior Clinical Research Associate

Kelly is hiring on behalf of an unnamed global life sciences client for a six-month clinical research project. The Senior Clinical Research Associate supports clinical studies by monitoring investigational sites, ensuring compliance and data quality, and coordinating study activities across the West Coast.

Responsibilities

• Conduct remote and on-site monitoring throughout the study lifecycle, following monitoring plans and risk-based monitoring practices
• Assess investigator sites for compliance with protocols, ICH-GCP, applicable regulations, SOPs, and project requirements
• Perform Source Document Review (SDR), Source Data Verification (SDV), and CRF review to support data quality and integrity
• Review investigational product inventory and related records
• Maintain regular communication with site staff and project stakeholders; track outstanding items and follow issues through resolution
• Identify site-level issues, apply critical thinking and root-cause analysis, recommend or support CAPA, and escalate concerns promptly
• Prepare timely, clear monitoring reports and follow-up letters; maintain essential documents and support audit readiness
• Participate in site selection and initiation, investigator meetings, and study close-out activities, including retrieval of trial materials
• Update CTMS and other study systems, provide progress updates, and complete report quality checks as required
• Support study administration, including investigator payment processes, expense reports, and timesheets
• Contribute to project tools and process improvements; experienced CRA II candidates may also mentor colleagues, review trip reports, lead team calls, or support project communications

Preferred

• large CRO experience is preferred
• Experience with complex therapeutic studies is required; large CRO experience is preferred
• Large CRO Experience
• Complex Therapeutic Study Experience

Benefits

• Remote work from a major city in California, Nevada, Colorado, Utah, or Arizona

Company

• Staffing and workforce solutions connecting organizations with workers
• Troy, Michigan, USA
• https://www.kellyservices.com/
• Founded in 1946
• 10001+ employees

Qualifications

• Bachelor's degree in a life-science-related field, RN credential, or equivalent relevant academic or vocational qualification
• Recent CRA monitoring experience: candidates must have monitored within the past six months
• Practical knowledge of clinical monitoring, medical terminology, ICH-GCP, applicable regulations, and essential study documentation
• Familiarity with risk-based monitoring and the ability to use critical thinking and problem-solving to resolve site issues
• Strong written and verbal communication, organization, attention to detail, and time management
• Proficiency with Microsoft Office and the ability to work with EDC and CTMS platforms
• Ability to work effectively both independently and with cross-functional teams
• CRA I: At least 2 years of clinical monitoring experience as a CRA
• Experience monitoring complex therapeutic studies is required
• At least 3 years of on-site monitoring experience, including monitoring within the past six months
• Large CRO monitoring and contract or project-based support experience are required
• Candidates should have experience with complex therapeutic areas such as oncology, neurology, CAR-T, rare disease, or similar
• Large CRO experience is preferred
• Experience with complex therapeutic studies is required; large CRO experience is preferred
• CRA I: At least 2 years of clinical monitoring experience as a CRA.
• At least 3 years of on-site monitoring experience, including monitoring within the past six months.

Required skills

• CAR-T, Clinical Monitoring, Clinical Trial Management Systems (CTMS), Complex Therapeutic Studies, Electronic Data Capture (EDC), ICH-GCP, Medical Terminology, Microsoft Office, Neurology, Oncology, Rare Disease, Risk-Based Monitoring

Preferred skills

• large CRO experience is preferred

Experience

• 2+ years