Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Initiation Clinical Research Associate - iCRA
Job ID R0000045120 , BrazilThe Initiation Clinical Research Associate (iCRA) is responsible for leading and executing all study start-up, pre-SIV, activation, and protocol amendment activities from site identification through site activation and maintenance. Acting as the primary contact for assigned sites, the iCRA manages regulatory submissions, site readiness, document quality, and activation timelines while ensuring compliance with sponsor, regulatory, and company requirements.
Key responsibilities include:
- Managing site start-up activities from feasibility and qualification through activation.
- Building strong relationships with investigators and site staff.
- Preparing, reviewing, negotiating, and executing regulatory and site documents, including CDAs, ICFs, translations, and amendments.
- Coordinating submissions and approvals with IRBs/IECs, Ministries of Health, and Regulatory Authorities.
- Developing and tracking activation strategies, timelines, and regulatory plans.
- Maintaining high-quality documentation in CTMS, eTMF, and TMF systems, ensuring First Time Quality (FTQ).
- Identifying, resolving, or escalating site issues and risks related to activation, recruitment, compliance, training, and data quality.
- Supporting sites with study system access, training requirements, and readiness activities.
- Ensuring sites remain audit- and inspection-ready throughout the study lifecycle.
- Maintaining compliance with ICH-GCP guidelines, local regulations, sponsor requirements, and Parexel SOPs.
- Collaborating cross-functionally to achieve project milestones and deliverables while proactively communicating progress, risks, and issues.
Required Skills and Experience:
- Strong clinical research and study start-up experience.
- Excellent problem-solving, communication, presentation, and stakeholder management skills.
- Ability to work independently, prioritize multiple tasks, and make decisions in ambiguous situations.
- Strong knowledge of CTMS, eTMF, TMF, and Microsoft Office tools.
- Experience working in global, matrix, and multicultural environments.
- High attention to detail, quality focus, and commitment to achieving project timelines.
- Excellent English skills (oral and written).
Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or another health-related field (or equivalent experience) is preferred.
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