in-house CRA, Czech Rep - FSP
- Employer
- Labcorp
- Location
- Prague, Czech Republic
- Salary
- Competitive
- Start date
- 13 Jun 2021
- Closing date
- 14 Jun 2021
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Covance is looking to recruit in-house CRA (Clinical Trial Coordinator) to join our sponsor in Czech Rep
Responsibilities :
- Trial and site administration:
- Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
- Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents o Assist with eTMF reconciliation
- Updating manuals/documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents
- Regulatory & Site Start-Up responsibilities:
- Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
- Budgeting, Agreement and Payments:
- Collaborate with finance/budgeting representatives for:
- Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval and maintenance (e.g. CTRAs)
- Update and maintain contract templates (in cooperation with Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures,
- Budget closeout.
- University Degree
- Proven experience in Clinical Research or relevant healthcare experience
- Fluent English and local language
Company
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.
- Website
- https://careers.labcorp.com/global/en
- Location
-
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert