Senior Clinical Research Associate

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Senior CRA to join our Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
At Premier Research, we are science-minded and heart-centered. Join us.
What you'll be doing:

Role: Site Manager

• Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.
• Manages assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs.

Role: Monitor

• Addresses non-compliance issues and trends at investigative site; develops, documents, and implements a CAP as necessary.
• Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.

Role: Quality and Process Improvement Champion

• Identifies and Reports complaints.
• Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute corrective action plans.

What we are searching for:

• Must have at least 6+ years of independent monitoring experience
• Must have knowledge of applicable clinical research regulations (FDA, GCP, ISO)
• Must have 4 year Bachelor's Degree
• Valid driver's license required
• Must have direct sponsor experience at a pharma or biotech
• Must be able to travel 50-75% nationally
• Strong communication and organizational skills required

Why choose Premier Research?

• Premier Research is more than a company –it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need
• Our cultural anchors –Caring & Empathy, Empowerment, Aspiration, One Team –mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.