Senior Clinical Research Associate
The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.
Emmes' European registered office is located in Prague, Czech Republic. Primary Purpose
T he Senior Clinical Research Associate is responsible for monitoring clinical research study sites, either on-site at investigative sites or remotely, to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The Senior CRA will conduct monitoring visits and activities in accordance with Emmes SOPs and applicable regulations. Up to 80 % travel to research sites or between corporate locations is required. Travel may include other countries, dependent upon project assignment. Responsibilities
- Ensures clinical study compliance with Good Clinical Practice (GCP), applicable regulations and SOPs
- Builds and maintains solid professional relationship with investigators and site
- Evaluates, initiates, monitors and closes out clinical study sites visits and prepares reports from these visits for an approval
- Facilitates subject enrollment at the site level with focused patient recruitment strategies and action plan
- Ensures appropriate safety reporting as well as tracking and reporting of adverse events
- Verifies case report forms against source documentation
- Performs investigational product/ medical device accountability and reconciliation
- Identifies site needs and site-related issues, escalates them and/or initiates corrective actions when necessary and responses to site-related queries and escalates site-related issues
- Assists in preparing sites for audits, reviews audit reports and contributes to resolve audit findings
- University degree in pharma/medical/natural sciences
- Experience in a pharmaceutical, biotech or CRO company or independent clinical monitoring experience
- Driving licence B and willingness to travel within the Czech Republic
- Fluent knowledge of Czech and English (both written and verbal)
- Good working knowledge of common software packages
- Strong customer focus, strong attention to detail, organizational skills
- Time management and prioritization
- Excellent communication skills
CONNECT WITH US!
- Interesting and independent work with career growth opportunities
- Competitive salary
- Friendly and professional environment
- Company car for business and private use
- One extra week of vacation
- Flexible working hours
- Possibility to work partially from home office
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