Job Description

Our client is an exciting clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. The Company has developed a proprietary technology designed to facilitate targeted drug delivery of both existing and novel drugs.

The current target application is currently in a Phase 1b/2 trial.Potential pipeline indications include candidates for other indications, each designed to improve on the activity and tolerability of currently approved drugs.
Location:Full Time; Seattle based

Scope: As Clinical Research Associate (CRA) you will be primarily responsible for the operational management and oversight of the client's clinical study's monitoring.

Travel requirement: Must be willing to travel domestically and internationally (approximately 20-25%), as needed

Reports to: SVP of Clinical Operations

Primary Responsibilities:

• Assisting Clinical Trial Manager in ensuring trials are initiated efficiently, completed on time, within budget and conducted in compliance with SOPs, regulations, and ICH/GCP guidelines
• Assisting Clinical Trial Manager in managing CRO partners and other vendors
• Working closely with and providing training to CRO staff, study site staff, and field-based CRAs
• Overseeing, conducting, and/or co- monitoring site qualification, study initiation, interim monitoring, and close out visits and completing associated reports
• Developing and/or assisting in the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
• Reviewing monitoring reports and monitoring visit letters written by CRO CRAs
• Driving CRO and trial sites with study startup activities, including IRB/IEC submissions and ensuring collection and review of required essential documents
• Creating, monitoring, and sharing key performance metrics with study teams
• Reviewing completed CRFs and data listings for accuracy, overseeing data discrepancy management, and performing associated training/retraining to site staff and CRAs as needed
• Developing strong and effective working relationships within Clinical Operations and other functional departments and CROs

Job Qualifications and Requirements:

• BS/BA in life sciences or related discipline
• 5+ years pharma/biopharma industry experience, preferably in a sponsor-side role
• 1+ years of active, independent, on-site monitoring experience for all types of visits
• Strong working knowledge of FDA and ICH/GCP regulations and guidelines
• Thorough knowledge of clinical monitoring procedures
• Strong interpersonal, communication (written and verbal), and organizational skills
• Excellent analytical and assessment skills, judgment, and problem-solving skills

Salary Range: $115,000 - $145,000 annually depending on education and relevant experience.

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