Clinical Research Associate

This position will work with the Coherus clinical team to support execution of global clinical studies for Coherus’ various products.  Depending on project complexity and level of experience, this may include supporting one or more clinical studies and/or managing a multi-national region for multiple global clinical studies. 

This position will assist in supporting the lead CPM in the oversight of contract research organizations, clinical laboratories, and other vendors, including clinical sites; collaborate with clinical development partners, as well as other internal departments to ensure that the clinical studies are conducted on time and within budget.  This position will also assist with the development of processes and infrastructure within clinical operations.

• →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
• →Perform other related tasks as requested.

The Base Salary Range for this position is $90,000 to $110,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.