Clinical Research Associate

The Clinical Research Associate will support the execution of global clinical studies for Coherus' various products, collaborating with the clinical team and managing vendors to ensure studies are conducted on time and within budget.

Requirements

• BS in life sciences.
• 3-5 years of experience of biotech/pharmaceutical clinical operations experience
• Strong experience in CRO and vendor management to support global clinical trials
• Understanding of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
• Demonstrated skills in writing/reviewing clinical study protocols, CRF designs, CSRs, regulatory documents (including IND/CTA, marketing application documents and annual/periodic updates) and developing study documentation.
• Understanding of data management, statistics and medical writing processes for clinical development.
• Ability to ‘roll up your sleeves’ and individually contribute results to clinical operations and company-wide goals
• Significant attention to detail, time management and organizational skills with the ability to multi-task and prioritize
• Ability to deal with time demands, incomplete information and unexpected events
• Proactive self-starter with the ability to take responsibility for tasks and execute them successfully with little supervision
• Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities
• Team-oriented with excellent communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
• Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.
• Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, MS Outlook, and MS Project) software

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Health, Dental, and Vision Insurance