Role : Clinical Research Associate (CRA) - B-Medical Devices Location: 7220 Trade Street, San Diego, CA 92121
Duration: 6 Months

Position Overview:
We are seeking a dedicated Clinical Research Associate (CRA) B for a long-term, fully on-site position. The ideal candidate will have 2-5 years of clinical research experience and be committed to working in person at our San Diego office.

Education Requirements:

• Bachelor's degree or higher in a relevant field.

Start Date:

• Looking to onboard the selected candidate ASAP after screening.

Key Responsibilities:

• Conduct on-site monitoring of clinical studies, ensuring compliance with protocols and FDA regulations.
• Assist with study start-up activities, including creating study binders, logs, and work instructions.
• Maintain effective communication with clinical sites through various channels (in-person, phone, email).
• Train site personnel on study procedures, including investigational product usage and data collection.
• Monitor study progress, assess protocol adherence, and verify source documents.
• Identify protocol deviations and draft monitoring reports and queries.

Key Skills Required:

1. Clinical Monitoring Experience: 2-5 years of experience in on-site and remote monitoring.
2. Study Management: Proficient in study start-up, monitoring, and close-out activities.
3. Independence and Initiative: Ability to work autonomously, complete training, and adapt quickly to new environments.

Additional Qualifications:

• Strong understanding of FDA regulations and clinical study design.
• Excellent organizational and communication skills.