Clinical Research Associate II (Full-Time)
Bold Steps Behavioral Health · Durham, NC · Today
On-siteAnalystFull-time
Role Overview: We are seeking a Clinical Research Associate II with independent on-site monitoring experience to support clinical trials in therapeutic areas such as CNS, cardiovascular, obesity, and MASH/NASH. Key Responsibilities: Conduct site selection, initiation, routine monitoring, and closeout visits following GCP, ICH, and regulatory standards.Build relationships with investigative sites, providing protocol, process, and study-specific training.Monitor study progress, including patient recruitment, data collection, and query resolution.Evaluate site performance, ensure compliance, identify risks, and escalate quality concerns as needed.Maintain accurate study documentation, regulatory records, and Trial Master File (TMF) readiness.Prepare monitoring reports and follow-up communications.Collaborate with cross-functional teams to support project milestones.Support patient recruitment and retention efforts at the site level.Assist with site financial and administrative activities, including invoicing when applicable. Qualifications & Skills Bachelor's degree required.At least 1 year of independent on-site monitoring experience in a CRO, biotech, or pharmaceutical setting.Knowledge of GCP, ICH, and clinical trial regulations.Strong communication, organizational, and problem-solving skills.Proficiency in Microsoft Office applications.