With offices in Berlin, Warsaw and Prague, KCR Placement is an international boutique provider of ‘fit for purpose’ resourcing solutions for a wide array of functions, including expert, managerial and senior executive ones. We specialize in finding the right talents for Pharmaceutical, Biotech, Medical Device companies and Contract Research Organizations across Europe.
Current Vacancy Highlights:
FirmaKCR PLACEMENT Sp z o.o
OgłoszenieCLINICAL TRIAL DOCUMENTATION ASSOCIATE / POLAND
Miasto/województwoOffice-based in Warsaw, Poland
Opis FirmyKCR Placement is a boutique provider of ‘fit for purpose’ resourcing solutions. We specialize in finding the right talents for pharma, biotech, medical device companies and contract research organizations (CROs) across Europe.
Founded as a sister company of KCR, a CRO operating in 19 countries in Europe as well as the U.S, we are supported by a great referral network of trusted professionals and provide full cycle recruitment services from job requisition to job offer. Our core services include Permanent Placement, Temporary Placement, Contract Placement, Executive Placement and Outplacement.
We offer tailor made solutions based on each project individual assessment and in-depth analysis. Our goal is to present you with a true ‘A-Player’ whose professional knowledge and personal skills guarantee ‘the perfect fit’ for your position.
KCR Placement has its offices in Berlin, Germany, Warsaw, Poland and Prague, Czech Republic. For more information please visit www.kcrplacement.com.
The duties associated with the role include:
- Assisting with the development and oversight of Trial Master File document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established procedures and policies.
- Preparing and is responsible for maintaining assigned Trial Master setup based on provided Document Management Plan.
- Preparing files from TMF according to communicated deadlines.
- Monitoring the TMF routinely for document availability using defined tools and/or routine procedures according to agreed upon metrics and performs escalation per process definition.
- Performing quality control of assigned TMF parts per documented schedule.
- Participating in preparation of the completed studies for archiving.
- Reporting about unresolved problems that appear during the cooperation process.
- Minimum of six (6) months of clinical research experience
- Knowledge of GCP including a basic understanding of regulatory requirements
- University / college degree
- Administrative skills
- Fluency in English
- Eagerness to learn medical / clinical research vocabulary and procedures
- Excellent organization skills, patience, attention to detail
- Very good communication skills
- Teamwork ability
- Computer competency