Initiation Clinical Research Associate II - EMEA HUB

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 looking for an Initiation Research Associate II for our team in Belgrade, Serbia. This role is focused on ICF preparation (customization) and on reviews of ICF and SRP for EMEA region predominantly.

We are looking for someone who speaks a second European language. Preferences would be – German, Danish, Norwegian, Swedish.

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 part of one of the core teams supporting the implementation of harmonized and centralized submission of studies via Clinical Trials Information System (CTIS) based on the new EU-CTR (Regulation no 536/2014);

Have the chance to develop, become the Subject Matter Expert (SME) for key client accounts, or for countries and also coaches in terms of specialized systems that we used (Veeva Clinical);

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 ICF amendments;

Review and approve updated/amended site documentation, including regulatory documents (as applicable)

Ensure timely and accurate completion of project goals and update of clinical 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;

Key Skills

English language proficiency;

Must speak a second European language. Preferences would be – German, Danish, Norwegian, Swedish.

Medical or pharmacy and similar science education background is a benefit, but not a must;

Experience with pharma business (both CRO and pharma companies) is a benefit, but not a must;

Technical skills – working with variety of systems;

Desire to work with documents, attention to detail, skilled/ willing to learn to work with many new exciting systems;

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