Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead-guided by our core values, we'll meet these challenges. Join us!

Alpine is seeking an in-house Clinical Research Associate/Senior Clinical Research Associate to assist with operational oversight of Alpine's clinical development programs for novel investigational products for the treatment of cancer and autoimmune/inflammatory disease. This individual will work alongside the Project Lead on CRO management, site management and site monitoring. This position is critical for helping ensure the timely, quality conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures, and all applicable regulations.

Duties and responsibilities
• Assist the Project Lead in managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
• Oversee CRO monitoring activities, including site qualification, study initiation, interim monitoring, and close out visits and completion of associated reports and follow-up letters
• Develop and/or assist 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, investigational product administration guidelines)
• Work closely with and provide training to CRO staff, study site staff, and field based CRAs
• Create, monitor, and present key study performance metrics with cross-functional Alpine study teams
• Work with the Medical Monitor, Director of Data Management, and Project Lead to review data listings for accuracy, oversee data discrepancy management, and perform associated training/retraining to site staff and CRAs as needed
• Work with the CRO to manage start-up activities at trial sites, including IRB/IEC submissions and ensuring the collection and review of required essential documents
• Escalate any issues in a timely manner to the Clinical Trial Manager
• Develop strong and effective working relationships within Alpine's Clinical Development team and other functional departments and CROs
• Ability to travel for periodic site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required

Qualifications
• BA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevant clinical trial management experience, preferable in a pharma/biotech setting.
• SOCRA or ARCP certification preferred.
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Highly responsive and proactive, a team player
• Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
• Exceptional attention to detail.
• Proficiency with MS Office products Word, Excel, PowerPoint, Share point

#LI-Hybrid

At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Professional level position, with a compensation range of $98,000 - $125,000 for a Clinical Research Associate and $124,000 - $136,000 for a Senior Clinical Research Associate. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees' satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).

Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.

Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine's culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.

Exciting challenges lie ahead-guided by our core values, we'll meet these challenges. Join us!