Source Documentation Specialist
Synexus
Warsaw , Poland
1 d. temu

Job Summary

Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you!

We are currently looking to attract a Source Documentation Specialist. In this role you can be home-based or working from one of our offices in Poland.

For the time being we can offer a 1-year contract.

As a Source Documentation Specialist, you will assist with the creation, completion, and maintenance of clinical trial source documents.

This includes the preparation of documents and assisting with responses to site staff members. This is a global position communicating with all AES countries worldwide.

Role Responsibility

Key responsibilities of the Source Documentation Specialist are :

  • Create, complete, maintain source documents for clinical studies
  • Review study protocols and utilize sponsor provided materials and other resources to include all essential elements of protocol into source documents
  • Manage the version control of source documents
  • Liaise with other functional / departmental managers / Investigators to understand all necessary aspects and needs of source documents & criteria, and to ensure it meets requirements
  • Distribute source documentation to site staff efficiently and in timelines
  • Ensure sites are using the correct source document
  • May be required to provide initial and ongoing training to site staff in the completion of documents
  • Ensure all source documents are prepared in accordance with GCP, ICH, FDA and other applicable regulatory guidelines
  • Ensure quality and compliance by following established SOPs, ICH / GCP, study-specific manuals and other applicable regulatory requirements
  • Ideal Candidate

    To be considered for this challenging opportunity you will need the following skills and experience :

  • At least 1 year of clinical research experience, or an equivalent combination of education and experience
  • Knowledge of medical terminology, clinical research protocols and source documentation
  • Detail orientated and inquisitive
  • Ability to work independently
  • Ability to work in a busy interactive environment and to perform tasks accurately and quickly
  • Extremely organised with strong time management skills
  • Strong computer and typing skills, strong proficiency in Microsoft Office programs (Outlook, Word, Excel) and Web applications and able to type proficiently (35+ wpm)
  • Ability to use software to develop organized information sources and to provide a variety of reports
  • Fluent Polish and English
  • Package Description

    Competitive salary and benefits; interesting job in a multinational company; open and friendly organizational culture; opportunity for training and professional development in the area of clinical trials.

    About Synexus

    Accelerated Enrolment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrolment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

    The array of integrated solutions includes PatientAdvantage, PPD’s global clinical development services optimized with Acurian and Synexus enrolment capabilities.

    Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network.

    When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.

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