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Clinical Trials Start-Up Specialist- UK and EU Wide



Business Type: Clinical Research Organisation
Job Type: Other
Job Level: Experienced (non manager)
Position: Full Time
Salary: *Attractive benefits package
Location: United Kingdom
Reference: 29880110
Closing Date: 03/10/21
Job Details:

Position

You will act within the Trial Start-Up and Regulatory Unit, under the supervision of the Head of Trial Start-Up and Regulatory Unit and of the Trial Start-Up Coordinator.

You''ll be accountable for:

  • Taking responsibility for deliverables at country level for Stat Up activities with a high level of quality;
  • Prepare all required documents for country application to Regulatory Authorities and Ethics Committees;
  • Prepare the documents modified according to the Ethics Committee request (e.g. Patient Information and Consent form, Letter to the GP, site-specific forms, etc.);
  • Prepare and submit CEC, LEC, and RA applications, ongoing submission (Amendments), periodic notification, as required;
  • Prepare and finalize the financial agreement/addendum with the Site;
  • Completion and maintenance of the National Database of Clinical Trials
  • Obtain the necessary authorizations within the set time-frames, ensuring the quality of documentation in compliance with ICH GCP, and applicable regulations and procedures;
  • Liaise with internal team members and with Sponsor to discuss areas with an impact on start-up activities and deadline; on a regular basis, send to the Sponsor the updated tracking of ethical and administrative authorizations;

Requirements

  • At least one/two years of experience in a similar position;
  • Knowledge of GCP;
  • Able to manage trial start-up activities, guaranteeing the security of information, under the supervision of the Head of the Trial Start-Up and Regulatory and with the coordination of the Trial Start-Up Coordinator;
  • Ability to work independently;
  • Ability to manage multiple activities simultaneously;
  • Good interpersonal skills;
  • Good English, both written and oral.

If this job appeals to you please apply here or send your CV to me, Aleksandar Chernev, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest-growing specialized life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, the US, and the Czech Republic and we hold labor leasing licenses for all EU8 countries. Please visit our website for a full list of the niche markets we cover.



NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 26/09/2021 | NPJ Ref: 284665
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