Clinical Research Associate II - Senior CRA

October 23

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues. • Build relationships with investigators and site staff. • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. • Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. • Generate visit/contact report. • Ensure timely and accurate completion of project goals and update of applicable trial management systems. • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations. • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, and study specific procedures, plans and training. • Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Requirements

• Sound problem solving skills. • Able to take initiative and work independently, and to proactively seek guidance when necessary. • Advance presentation skills. • Client focused approach to work. • Ability to interact professionally within a client organization. • Flexible attitude with respect to work assignments and new learning. • Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. • Willingness to work in a matrix environment and to value the importance of teamwork. • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word. • Strong interpersonal, verbal, and written communication skills. • Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables. • Effective time management in order to meet study needs, team objectives, and department goals. • Developing ability to work across cultures. • Shows commitment to and performs consistently high quality work. • Ability to successfully work in a (‘virtual’) team environment. • Consulting Skills • Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned. • Attention to detail. • Holds a driver’s license where required