Note! This job has been aggregated through external sources, the Apply link will take you to the company's website.

Clinical Research Associate Job in Czech Republic
TFS , Czech Republic

Never pay for job application, test/interview.
Safe Job Search | EEO Laws in Czech Republic
1 Year
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
Career Level
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Apr 6, 2021
Last Date
Jul 6, 2021

Job Description

The Clinical Research Associate (CRA) is part of Clinical Operations or Strategic Resourcing

Solutions Unit within TFS Develop and will function operationally as a member of a Project Team and

is responsible for the initiation, onsite and remote monitoring and termination of investigative sites

during study conduct, according to company policies, SOPs and regulatory requirements.

The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and


  • Monitor on-site and remotely clinical trials in accordance with TFS and/or client company. Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
  • Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
  • Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
  • Initiates corrective action to resolve issues as directed by supervisor
  • Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager
  • Participate in contract handling and negotiation directed by Lead CRA/Project Manager
  • Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
  • In cooperation with study team, responsible for SMF maintenance
  • Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
  • Order, ship and coordination of study supplies at site
  • May prepare and submit status reports as directed by Lead CRA/PM
  • Review and support site staff to maintain SMF
  • Review Informed Consent documents for essential elements and protocol specifics
  • Update CTMS system with site and study information
  • May audit data in tables and text of clinical summaries
  • May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness
  • Prepare check requisitions for sponsor Project Manager approval, when applicable


  • Bachelor’s Degree, preferably in life science or nursing; or equivalent
  • Minimum 1-3 years of relevant clinical experience
  • Able to work in a fast paced environment with changing priorities
  • Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
  • Possess the understanding of Good Clinical Practice regulations, ICH guidelines
  • Ability to work independently as well as in a team matrix organization
  • Excellent written and verbal communication skills.
  • Excellent organizational skills


  • Private Health Coverage
  • Global General Liability Insurance
  • Global Travel Insurance
  • Car Allowance
  • Internet costs are covered by TFS
  • Flexible working schedule
  • Work From Home

Job Specification


Information Technology and Services - Durham, United States