Contract CRA

Clinical Research Associate (CRA)

Remote, Travel: Up to 75%

3-6 Month Contract (Possibility for Extension)

About the Role:

The Clinical Research Associate serves as a key contributor to clinical site management and monitoring across diagnostic clinical programs. Operating with a high degree of independence, this individual ensures adherence to study protocols, ICH-GCP guidelines, and applicable regulations while maintaining inspection-ready execution across assigned sites and studies. The CRA partners closely with Clinical Trial Managers and cross-functional teams to drive site performance, data integrity, and consistent monitoring standards.

Reports to: Sr. Manager, Clinical Site Operations

What You Will Do:

• Site Management and Monitoring
• Execute on-site and remote monitoring visits for assigned sites in accordance with the Clinical Monitoring Plan, ICH-GCP guidelines, and applicable regulations
• Conduct source data verification to confirm CRF data is accurate, complete, and consistent with source documents and the study protocol
• Manage day-to-day site relationships, driving enrollment momentum, query resolution, and overall site performance
• Proactively identify and document site-level risks, protocol deviations, and data trends, escalating issues to Clinical Trial Managers with recommended corrective actions
• Prepare and submit timely, high-quality monitoring visit reports that provide clear visibility into site health and compliance status
• Regulatory and Document Management
• Oversee the collection, review, and maintenance of essential regulatory and study documents to ensure ongoing inspection readiness
• Evaluate and maintain investigator site files and the Trial Master File per sponsor SOPs and the TMF reference model, proactively resolving document gaps
• Support study start-up activities including site qualification, initiation visits, and regulatory document collection
• Contribute to study close-out activities including final monitoring visits, query resolution, and site-level documentation completion
• Safety and Compliance
• Monitor subject safety throughout the study including timely review and assessment of adverse events and serious adverse events, escalating safety signals promptly per sponsor and regulatory requirements
• Develop, track, and confirm implementation of corrective and preventive action plans with sites following identification of protocol deviations or compliance issues, verifying effectiveness at subsequent monitoring contacts
• Training and Mentorship
• Facilitate and support site staff training on protocol requirements, eClinical systems, and study-specific procedures at initiation and on an ongoing basis
• Mentor junior CRAs on monitoring standards, documentation practices, and site management techniques to support consistent execution across the team
• Cross-functional Collaboration
• Collaborate with Clinical Trial Managers and cross-functional partners to provide site-level input into study planning, risk management, and operational decision-making

Required:

• Bachelor's degree in a life sciences or health-related field or equivalent combination of education and experience
• 4 or more years of clinical monitoring experience including independent on-site and remote monitoring across multi-site studies
• Experience monitoring studies for diagnostics, IVD, or regulated medical device products with familiarity with FDA device regulatory pathways strongly valued
• Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations including 21 CFR Parts 11, 50, 54, 56, 312, and 812, and applicable local requirements governing clinical research
• Familiarity with risk-based monitoring frameworks and central monitoring methodologies
• Demonstrated ability to manage a site portfolio independently including enrollment tracking, query management, protocol deviation documentation, and escalation
• Proficiency with EDC systems including iMediNet, Medidata Rave, Oracle InForm, and Veeva Vault EDC, as well as CTMS and eTMF platforms including Veeva Vault TMF and Complion
• Proficiency in Microsoft Office Suite and Google Workspace
• Strong written and verbal communication skills with the ability to author clear monitoring visit reports and professional site correspondence
• Excellent organizational and time management skills with the ability to manage a high-volume site portfolio and meet deadlines
• Ability to exercise sound judgment and work independently in ambiguous or high-pressure situations
• Ability to travel up to 80% of the time including on short notice
• Valid driver's license required

Preferred:

• ACRP or SoCRA certification
• Experience monitoring in infectious disease, microbiology, or molecular diagnostics studies
• Experience mentoring or training junior CRAs on monitoring practices and documentation standards
• Familiarity with laboratory-developed test and CLIA regulatory frameworks