Clinical Research Associate
7 days ago
AriBio, a rapidly growing clinical stage biotech firm dedicated to developing innovative treatments for neurodegenerative diseases, is seeking a highly motivated Clinical Research Associate (CRA) to join our team in San Diego.
About the RoleThis position is instrumental in ensuring the successful execution and oversight of clinical trials. The CRA will collaborate with cross-functional teams to manage and support clinical studies in compliance with all applicable regulations, guidelines, and SOPs.
Key Responsibilities- Monitoring and Compliance
- Conduct comprehensive monitoring visits to ensure compliance with the clinical trial protocol, SOPs, ICH-GCP, and other regulatory requirements.
- Site Management
- Lead site training sessions and ensure accurate documentation and data collection in clinical trials.
- Manage site performance, addressing site issues to align with project goals and timelines.
- Data Integrity
- Review and validate clinical site activities, ensuring precise data capture and reporting.
- Develop and maintain tracking systems for study details, site compliance, patient recruitment, and trial metrics.
- Collaboration and Communication
- Support the development and review of study materials, including CRFs and informed consent documents.
- Assist with the management and resolution of data queries to maintain data integrity.
- Contribute to the ongoing quality review and final reconciliation of the Trial Master File (TMF).
- Bachelor's degree required.
- A minimum of 3 years' experience of on-site clinical research monitoring with a CRO or sponsor.
- Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.).
- Strong understanding of clinical trial processes, protocols, and medical terminology.
- Degree in life sciences field a plus.
- Participation in global Phase trials in CNS indications is preferred.
This role is primarily on-site and is located in our San Diego office. Remote work is available one day per week. Willingness to travel as required by the study protocol. We offer competitive compensation and benefits packages.
Salary$120,000 - $140,000 per year.
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