Clinical Research Associate II / Sr CRA – Full Service | Home-Based (Central US)
Location: USA – Remote (Central US)
Job Type: Full-Time
Job ID: 25102606
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization, accelerating clinical development, medical affairs, and commercial strategies. Our patient-centric model ensures efficient delivery of clinical trials and therapies, while promoting innovation and collaboration across all teams.
With 29,000 employees across 110 countries, we provide a growth-oriented environment, career progression, and a culture that values diversity, inclusion, and professional development.
Role Overview
We are seeking a Clinical Research Associate II / Senior CRA to support remote and on-site monitoring of clinical trials. This role ensures regulatory compliance, data integrity, and patient safety across study sites while applying risk-based monitoring and data analytics.
Ideal candidates are experienced in ICH/GCP guidelines, protocol compliance, and site management, and have the ability to work independently in a home-based environment.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
Evaluate site performance, protocol adherence, and regulatory compliance; escalate serious issues and develop corrective action plans.
Review informed consent procedures and ensure patient confidentiality.
Perform source document verification and CRF review; manage query resolution to ensure data completeness and accuracy.
Support investigational product (IP) accountability, including inventory, storage, dispensing, and administration tracking.
Reconcile Investigator Site Files (ISF) with Trial Master File (TMF) and ensure essential documents are archived per local regulations.
Project & Communication Management
Document monitoring activities through trip reports, follow-ups, and communication logs.
Track recruitment, retention, and site performance metrics.
Collaborate with site staff, sponsor affiliates, and cross-functional teams to maintain study timelines and deliverables.
Train and guide junior staff as required; provide site-level and project-level guidance on audit readiness.
Regulatory Compliance & Quality Assurance
Maintain working knowledge of ICH/GCP, local regulations, and company SOPs.
Ensure study sites comply with electronic data capture requirements and data quality standards.
Participate in project meetings, investigator meetings, and training sessions as required.
Support audit preparation and follow-up actions.
Required Qualifications
Education & Experience:
Bachelor’s degree or RN in a relevant field; equivalent combination of education and experience considered.
Knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
Demonstrated proficiency with computer systems and data capture technologies.
Ability to manage extensive travel up to 75%.
Skills & Competencies:
Excellent communication, presentation, and interpersonal skills.
Ability to adapt to changing priorities while managing multiple tasks and projects.
Strong organizational, analytical, and problem-solving skills.
Independent and team-oriented with a proactive approach to site and project management.
Why Join Syneos Health
Work on home-based, remote, and on-site clinical monitoring across multiple therapeutic areas.
Gain experience in risk-based monitoring, data analytics, and clinical trial oversight.
Collaborate with global project teams and enhance your professional expertise.
Enjoy comprehensive benefits, including health coverage, 401k matching, stock purchase plans, flexible PTO, and opportunities for performance-based incentives.
Apply Now
Advance your career as a Clinical Research Associate II / Senior CRA with Syneos Health, contributing to patient safety, high-quality clinical research, and regulatory compliance across global clinical trials.
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