Clinical Research Associate II

ClinLab Solutions Group; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

ClinLab Solutions Group is seeking a CRA II to conduct on-site and remote monitoring across assigned sites and studies in diagnostic clinical programs. You will manage site relationships, perform SDV/SDR, and escalate issues with actionable recommendations. Reports to Sr.

Manager, Clinical Site Operations. Requires 3+ years of monitoring experience, familiarity with FDA/ICH-GCP, and up to 80% travel. You will mentor junior CRAs and collaborate cross-functionally to ensure inspection-ready

Qualifications

• Bachelor's degree in life sciences or health-related field or equivalent
• 3+ years of clinical monitoring experience including on-site and remote monitoring across multi-site studies
• Experience with diagnostics/IVD or regulated medical devices preferred
• Strong knowledge of ICH-GCP E6(R2) guidelines and FDA regulations (21 CFR 11/50/54/56/312/812)
• Familiarity with risk-based monitoring and central monitoring
• Ability to travel up to 80% and work independently

Responsibilities

• Execute on-site and remote monitoring visits per plan and guidelines
• Perform source data verification to ensure data accuracy and consistency
• Manage day-to-day site relationships and drive enrollment momentum
• Identify site risks and protocol deviations with corrective actions
• Prepare monitoring visit reports with clear site health status
• Oversee regulatory document collection and TMF maintenance
• Support start-up activities and site initiation visits
• Contribute to study close-out activities and documentation

Skills

Clinical monitoring

Source data verification

Regulatory compliance

ICH-GCP knowledge

Documentation

Time management

Travel readiness

Team mentorship

Education

Bachelor's degree in life sciences or health-related field

Tools

iMediNet

Medidata Rave

Oracle InForm

Veeva Vault EDC

Veeva Vault TMF

Complion

Job description

The CRA II performs independent on site and remote monitoring across assigned sites and studies within diagnostic clinical programs. This role manages site relationships with a high degree of autonomy, conducts rigorous source data verification (SDV) and source data review (SDR), and drives timely resolution of findings, queries, and protocol deviations. The CRA II is a dependable operational contributor who proactively identifies risks and escalates issues with appropriate recommendations, while maintaining inspection ready documentation.

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

What You Bring

Required

• Bachelor's degree in a life sciences or health-related field or equivalent combination of education and experience
• 3 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 framework