• Salary: Competitive
  • REF Number: 00033027
  • Consultant: Charlene Dutchman
  • Contact: 01246 457733
  • Date Published: 24.08.2015
  • Closed Date: 29.01.2016
  • Sector:
  • Location: UK Wide,
  • Discipline:

Charlie Dutchman at CK Clinical is recruiting for a number of Clinical Research Associates at CRA I/CRAII/Senior CRA levels to join a large global clinical research organisation, with headquarters based in Berkshire, on a full time, permanent, basis.Please note these roles are field based and vary in location so it is not necessary that the individual is based in Berkshire.

Key Accountabilities/Responsibilities of Clinical Research Associate I/II/Senior CRA will include:

  • All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties.
  • All aspects of site and registry management as prescribed in the project plans.
  • Organizing and making presentations at Investigator Meetings.
  • Reporting, writing narratives and follow-up on serious adverse events
  • Reviewing progress of projects and initiating appropriate actions to achieve target objectives.
  • You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required.
  • Participating in the development of protocols and Case Report Forms as assigned.
  • Interacting with internal work groups to evaluate needs, resources and timelines.

As a Clinical Research Associate I/II/Senior CRA, you will have the following qualifications, skills and experience:

  • University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
  • Relevant clinical research experience in pharmaceutical or CRO industries.
  • Experience with in relevant therapy area is desirable and experience with in early clinical development is essential for some studies. (Please note we invite applications from all therapy areas as there are multiple roles on offer).
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
  • Excellent site monitoring and management skills
  • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Fluency in local and English language.
  • Ability to train and supervise junior staff.
  • Ability to work under minimal supervision.
  • Good planning, organization and problem solving abilities.
  • Good communication and interpersonal skills.

For more information or to apply for this Clinical Research Associate II/Senior CRA position please contact Charlene Dutchman on 01246 45 77 33 or email Alternatively, please click on the link to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33027 in all correspondence.

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