Senior Clinical Research Associate, Neuroscience (Contract)

11 Premier Research International LLC; Nevada (IA); On-site; USD 90,000 - 120,000; Full time

Job summary

Premier Research seeks a Senior Clinical Research Associate, Neuroscience (Contract) to support your Clinical Monitoring, Site Management and SSU teams. This full-time contract for 6 months focuses on ensuring data integrity, subject safety and protocol adherence across multiple sites with remote and on-site monitoring as needed.

You will contribute to monitoring plans, qualification visits, and study initiation while collaborating with the Clinical Lead to optimize site performance and issue

Qualifications

• Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per CMP timelines
• Monitors data integrity and subject safety per ICH GCP/ISO14155 and client requirements
• Manages monitoring activities (remote or on-site) per CMP and regulatory requirements
• Plans day-to-day monitoring activities and sets site priorities
• Prepares for and conducts site qualification, study initiation, interim monitoring, dosing observation, and close-out visits
• Collaborates with Clinical Lead to enhance site visits and manage trial issues

Skills

Neuroscience monitoring

ICH-GCP/ISO14155 knowledge

FDA guidance documents

Study coordination

Education

Bachelor degree in clinical, science, or health-related field

Licensed health-care professional (RN)

Job description

Premier Research is looking for a Senior Clinical Research Associate, Neuroscience (Contract) to join our Clinical Monitoring, Site Management and SSU 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. This is a full-time contract position for 6 months.

What You'll Be Doing:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines
• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
• Monitors (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP
• Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase

What We Are Searching For:

• Must be located in CA, NV, GA, or FL
• Neuroscience monitoring experience highly prioritized
• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Patient facing, study coordinating experience preferred
• Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures
• Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted
• Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities, self-starter
• Travel up to 70-85%

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

Premier Research is more than a company - it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. 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.

Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.