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Clinical Trial Specialist 2 October, 2018

Job Title: Clinical Trial Specialist

Reports to: Clinical Project Manager

Type of Position: Full-time

Clinical Venture Services Ltd provides clinical study support services to the medical device community with a specialist interest in early and late phase start-up med-tech and bio-tech industries. Currently the preferred clinical partner for ReCor Medical Inc. a US-based subsidiary of Otsuka Medical Devices, exploring device-based therapies for hypertension, we are recruiting for a clinical trial specialist. The role will support the in-house daily activities of clinical study site support including regulatory document creation, submission and filing. The ideal candidate would have a strong background in clinical trial administration and be independent and proactive; able to think critically and happy to work in small dynamic teams.

Responsibilities include:

  • Provide support with study start up documentation, Site Qualification reports, Ethics Committee/IRB submissions, renewals etc
  • Review of regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
  • Ensure all documents are filed in the TMF appropriately
  • Collaborate with study team members to maintain consistent case report form data qualityand discrepancy resolution across sites. May include remote data monitoring via the

    electronic case report form

  • Creation of reports to monitor site-specific metrics, compliance and data quality
  • Provide support to facilitate clinical study payment process as required
  • Support with inventory logistics, control and tracking of investigational product
  • Perform general clerical duties including: photocopying, mailing and filing
  • Additional office management and general administrative functions as needed

Skills/Requirements:

  • Educated to degree level at minimum preferred
  • 2+ years in clinical administration in pharmaceutical or medical device industry orequivalent preferred. Background in nursing an advantage
  • Proven experience in office admin, data entry; data tracking and clinical trial processpreferred
  • Experience with online databases
  • Experienced user of Microsoft Office at minimum (Word; Excel; PowerPoint)
  • Ability to work as part of a small dynamic team
  • Fluent in English, additional languages (French, German, Dutch) an advantage preferred

Rewards:

  • Competitive Salary dependent on experience
  • Discretionary Bonus
  • Pension
Interested applicants should send a cover letter and copy of their CV to clinvenservices@recormedical.com or contact Jane Gregory on +44 (0) 1304 806 862.

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