Company

KCR

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Clinical Trial Documentation Associate (UA)

City/voivodeship

Kiev

Publication

2018-04-25

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Contract Research Organization (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Clinical Trial Documentation Associate. This is a permament position in one of the company's Operational Hubs in Kiev (UA)
Location: Kiev (office-based)
 
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.
Requirements:
  • At least one (1) year of clinical research experience
  • Knowledge of GCP including a basic understanding of regulatory requirements
  • Very good knowledge of TMF (TMF Veeva Vault experience will be asset)
  • University / college degree
  • Administrative skills
  • Fluency in English
  • Eagerness to still learn medical / clinical research vocabulary and procedures
  • Excellent organization skills, patience, attention to detail
  • Very good communication skills
  • Teamwork ability
  • Computer competency
 
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits
that comply with national regulations and provide the coverage that best meets employee needs.

To show that you are appreciated in our team, while working at KCR you will be provided with: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
If you wish to apply, please submit your CV using the button below.