Senior Clinical Research Associate (FSP)
Premier Research is looking for a Senior Clinical Research Associate to join our Functional Services team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
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.
- Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.
- Addresses non-compliance issues and trends at investigative site; develops, documents, and implements a CAP as necessary.
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 4 year Bachelor's Degree
- Must have at least 6+ years of independent monitoring experience
- Must have knowledge of applicable clinical research regulations (FDA, GCP, ISO)
- Must be able to travel 50-75% nationally
- Must have direct sponsor experience at a pharma or biotech
- 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.