Premier Research is looking for a Senior Clinical Research Associate (Phase I, Central Region) 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 BiotechTM. Join us and build your future here.
What You’ll Be Doing:
- Issues, investigates, and resolves any data discrepancies identified during source verification activities
- Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
- Maintains thorough documentation and proper escalation of issues related to visit reports.
- Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations.
- Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.
- Supports regulatory inspection activities as required.
What We Are Searching For:
- Bachelor degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
- 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities, previous experience in a sponsor-embedded FSP model highly preferred. Alternately, must have proven experience in all primary job functions.
- Demonstrates excellent English verbal and written communication skills
- Phase I and Cardiology experience highly preferred
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
- Must be located in the South East Region in the United States
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 Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, 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.
