Clinical Research Associate II (Full-Time)
Company: Bold Steps Behavioral Health
- Location: Durham, United States
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
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.
