Role Summary
Clinical Research Associate responsible for supporting the execution of clinical studies across the precision psychiatry portfolio. Oversees assigned investigative sites, ensuring studies are conducted efficiently, compliantly, and with scientific rigor. Serves as the key liaison between clinical sites and the clinical operations team, driving recruitment, monitoring data quality, and maintaining high standards of Good Clinical Practice (GCP).
Responsibilities
- Manage site activities from initiation through closeout, ensuring compliance with GCP and study protocols.
- Monitor study progress, data accuracy, and regulatory documentation.
- Train and support site staff on study procedures and investigational product handling.
- Identify and resolve site issues promptly to maintain timelines and data quality.
- Collaborate cross-functionally to achieve clinical and operational goals.
Qualifications
- BS in a scientific field or pharmacy, RN, or BSN degree (or equivalent).
- 1–3 years of clinical monitoring experience (CRO, biotech, or pharma), including on-site or remote monitoring experience.
- Strong understanding of GCP/ICH-E6 and clinical research operations.
- Excellent communication, organization, and problem-solving skills.
- CCRA certification and experience with rater-administered measures required.
Location
Remote with approximately 60% travel