Initiation Clinical Research Associate II/Senior iCRA (Study Start Up)

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for an Initiation Clinical Research Associate II/Senior ICRA (Study Start- Up) for the EMEA Centralized reviewers’ team across to be based in Czech Republic. This role focuses on ICF preparation (customization) and on reviews of ICF and SRP.

Through your work in this role you will: Become a part of the international growing team, supporting core Parexel business and key clients who stand behind the key breakthrough therapies Support all countries in EMEA region (and some countries from other regions as well), with focus on key countries like Germany Be a part of one of the core teams supporting the implementation of new and long awaited way of performing clinical trials start-up in Parexel: harmonized and centralized submission of studies via Clinical Trials Information System (CTIS) based on the new EU-CTR (Regulation no 536/2014) that is finally coming in force from 31 January 2022 Have the chance to develop, the be SME for key client accounts, or for countries and also coaches in terms of specialized systems that we used (Veeva) Be part of the group with high team spirit and mutual support Role Responsibilities Customize, review as needed, country/site specific Informed Consent Forms (ICF) Customize any ICF amendments Review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable Ensure timely and accurate completion of project goals and update of

applicable trial management systems. Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. Show commitment and perform consistent high quality work. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s)

in an open, balanced, objective manner, modeling the high performance culture values. Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs,

other Parexel / Sponsor training requirements and study specific procedures, plans and training. Ensure basic understanding of milestones and strive for high quality, timely, and efficient delivery. Provide input and feedback for Performance Development Conversation(s). Proactively keep manager informed about work progress and any issues. Develop expertise to become a subject matter expert. Work in a self-driven capacity, with limited need for oversight Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc. QualificationsKey Skills English language proficiency Medical or pharmacy and similar science education background is a benefit but not a must Experience with pharma business (both CRO or pharma companies) is a benefit but not a must Technical skills – working with systems – is beneficial Desire to work with documents, attention to detail, skilled/ willing to learn to work with many new exciting systems Able to organize work efficiently, able to multitask and in parallel be able to prioritize as needed (in consultation with LM as needed) Strong communication skills Willingness to learn new things, be flexible, open-minded, able to work under some stress (has some strategy to cope)