ICRA/SSU Administrator
Serbia, Remote Additional Locations Bucharest,Romania;Budapest,Hungary;Kyiv,Ukraine;Prague,Czechia Job ID R0000030263 Category Clinical Trials Date Posted 01/02/2025Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
About This Role
Parexel 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
#LI-REMOTE
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
