Clinical Research Associate I – II

🕒 January 29

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 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 • 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 • Ensure sites are compliant with project specific training requirements • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary • Address and resolve issues at sites, including additional training and communication • Collect, review, and approve updated/amended site documentation • Perform on-site visits including Qualification and Initiation visits • Conduct remote visits/contacts as requested/needed • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations • Ensure timely and accurate completion of project goals and update applicable trial management systems • Provide strategy for efficient project planning and goal completion • Ensure that assigned sites are audit and inspection ready

🎯 Requirements

• CRA experience from AUS or NZ is required (at least 1 year of independent monitoring) • 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 decisions 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 and preserving patient safety. • 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. • Able to accommodate extensive travel time requirements, according to task allocation/phase of the study assigned. • Holds a driver’s license where required.

🏖️ Benefits

• Open to consider experienced CRAs based in Melbourne or Sydney.