Clinical Research Associate II

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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 point of contact with assigned sites, accountable for quality and delivery during the start-up phase • Build relationships with investigators and site staff • Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities • Prepare, negotiate, and facilitate execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments • Conduct remote Qualification Visits (QVs) • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents • Customize, review, and negotiate country/site specific Informed Consent Forms (ICF), translations, and amendments • Submit IRB/IEC and MoH/RA application(s) and ensure timely and accurate completion of project goals • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations

Requirements

• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology • 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