Job Description

Job Description

Job Description

Summary
We are seeking a motivated individual to join our Clinical Department as an In-House Clinical Research Associate (CRA). Ideal candidates will be self-driven and committed to generating high-quality data within an innovative research team. The CRA will support the administration and progress of clinical trials, ensuring compliance with protocols for accurate data collection.

Location
San Diego – onsite

Responsibilities:

• Assist in identifying and setting up trial sites with necessary materials.
• Manage study start-up activities and track metrics (e.g., feasibility data, consent form review).
• Ensure regulatory compliance with SOPs, FDA regulations, and ICH guidelines.
• Review and approve monitoring visit reports.
• Identify potential data collection issues through periodic data reviews.
• Collect completed Case Report Forms (CRFs) and maintain the Trial Master File.
• Support the data query process and verify internal data listings.
• Generate reports and manage trial documentation.
• Track patient enrollment and recommend solutions to enhance recruitment.
• Utilize clinical trial databases (e.g., EDC, CTMS) for reporting.
• Assist in preparing study documents and designing materials (CRFs, patient diaries).
• Participate in protocol development and study reports.
• Coordinate training materials for site staff.
• Archive study documentation and correspondence.
• Contribute to research reports and presentations.
• Establish relationships with collaborative partners and maintain safety standards.
• Other duties as assigned.

Qualifications:

• BA/BS in a health-related field; clinical research or life sciences preferred.
• Minimum 5 years of relevant clinical research experience.
• Experience in clinical research monitoring or as a study coordinator.
• Knowledge of GCP, ICH guidelines, and FDA regulations.
• Proficiency in Microsoft Office Suite.

Requirements:

• Ability to work independently with minimal supervision.
• Excellent written and verbal communication skills.
• Strong problem-solving skills and proactive approach.
• Understanding of project timelines and coordination with stakeholders.
• Adaptable and flexible in managing multiple demands.
• Self-motivated with strong interpersonal and organizational skills.

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