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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 CRA/Site Initiation Specialist - FSP - Remote
Job ID R0000030263 , SerbiaParexel is currently seeking an experienced Study start up administrator to join us in Czechia, Romania, Serbia, Hungary and Ukraine, you be assigned to one of our key sponsors in the region.
Working as an Initiation CRA, you’ll be responsible for ensuring the completeness of Site Essential Document Packages as well as the Site Regulatory Packages. Reviewing essential documents, tracking and ensuring all files are in place in the eTMF.
Some specifics about this advertised role
- Dedicated to one client.
- Gathers all documents required for the purposes of enabling Site Initiation; includes the compilation of documents from multiple internal stakeholders and supporting functions to then distribute to the site in a structured and time sensitive manner.
- Review investigator site essential documentation packages from CROs per process and sample as needed
- May collaborate directly with sites regarding collection of documents and IRB timelines for site activation and ensure that relevant documents are uploaded into the eTMF.
- May represent Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities
Here are a few requirements specific to this advertised role.
- 3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.
- Strong familiarity with EUCTD/R and Federal Code of Regulations
- Familiarity with Veeva Vault Clinical for CTMS and eTMF use
- Excellent verbal and written influencing and training/mentoring skills, in local language and English
- Strong coordination and organizational skills
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