In-House Clinical Research Associate

Description
Position at Premier Research
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 talented and energetic In House CRA to join our Clinical Data Sciences 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 growth and success.
What You'll Be Doing

• Responsible for the timely identification and escalation of site performance and quality issues to the Clinical Lead (CL). Partners with Clinical Research Associates (CRAs) to ensure seamless management of assigned clinical sites.
• Frequently communicates with CRAs to share updates on assigned sites, discuss site issues and concerns, and define actions for resolving issues and deficiencies at the site; including dissemination of information according to the study-specific communication plan between sites, in house and regionally based staff to ensure project success
• Responsible for maintaining a level of data review consistent with the study Project Management Plan, Clinical Monitoring Plan, and other governing documents, as applicable.
• Provides site support to ensure clinical deliverables and site activation milestones are met. Demonstrates understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and adherence across assigned sites.
• Serves as the secondary contact for sites supporting CRAs/CL to convey project information and for study-related questions, discuss site-specific recruitment, follow-up on outstanding items, and ensure sites are receiving support necessary to meet study expectations
• Responsible for building strong, collaborative relationships with Clinical Leads, Project Managers, Investigators, and staff at assigned clinical sites frequently communicating to provide study updates, discuss site-specific recruitment, follow-up on outstanding items, and ensure sites is receiving support necessary to meet study expectations.

What We Are Searching For

• BS/BA degree (or its international equivalent) preferably in a scientific or health-related field.
• Strong written, oral communication, and organization skills and a strong attention to detail.
• Demonstrated ability to problem solve, work independently, learn new applications, meet timelines, and multi-task to complete multiple deliverables in parallel is required.
• Previous CRO experience preferred. An equivalent combination education and experience will be considered.
• Prior experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, regulatory compliance, and study coordination preferred.

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.