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Job Details

Sr Clinical Research Associate

Company: United BioSource Corporation.
Location: Madrid, Spain
Reference: REQ20014087
Closing Date: 10 Jul 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Specific Job Duties:Thorough knowledge and application of project specific protocolThorough knowledge of the local country laws applicable to clinical trials/ observational studies and ICH GCP. ...

Requirements:

For our Spanish operations we are looking for a Senior CRA

 

We offer freelance and fixed-term contracts opportunities!

Specific Job Duties:

 

  • Thorough knowledge and application of project specific protocol
  • Thorough knowledge of the local country laws applicable to clinical trials/ observational studies and ICH GCP.

 

  • Consistently completes on site monitoring visits (including pre-study, initiation, interim monitoring and close-out visits ) in accordance with project specific timelines
  • Consistently complete central monitoring call ( including pre-study, initiation, interim monitoring and close out call) in accordance with project specific timelines
  • Consistently complete remote monitoring activities in accordance with project specific timelines
  • Consistently completes travel scheduling in accordance with project specific and UBC guidelines
  • Attends project team meetings, department meetings as required.
  • Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections
  • Consistently ensures follow-up of site issues and action items per UBC/sponsor timelines
  • Consistently enters site visits/central monitoring calls, confirmation/follow-up letters and site monitoring reports into CTMS
  • Consistently ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol, and enter them into CTMS
  • Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
  • Consistently completes and maintain Regulatory Binder
  • Consistently ensure accurate training of PI and site staff on study procedures and protocol
  • Consistently submits expense reports within UBC timelines; consistently follows EU UBC Travel
  • Guidelines

  • Consistently completes UBC and/or Sponsor SOP review and documentation within requested timelines
  • Consistently completes expense reports within UBC timelines; adheres to EU UBC Travel Guidelines
  • Consistently completes sponsor specific training and documentation within requested timelines
  • Assists PM and management team with co-monitoring.
  • Assists management team by mentoring and co-monitoring of other CRAs
  • Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training
  • Assists management team by leading Sponsor local TCs, if required in local lenguage
  • Accurate input into production of local language version of Patient Information Sheet and Informed Consent
  • Review of translations according to UBC/sponsor SOPs
  • Translation from/into local language into/from English for complete study specific communication
  • Review and input into study protocol and case report form (CRF) review
  • Consistently preparation, submission and tracking of Competent Authority, local ethics committee and other regulatory applications
  • Consistently contract negotiation with hospitals and local R&D Departments
  • Consistently review and confirm of visits/ processes to be paid to the site as per contract and communication to CSS/PAI/PAII (as delegate) for payment management: file, track, and log of site project invoicing
  • Data Management Department data query resolution
  • Check of EDC tools and if required translation into local language
  • Administrative and logistical support to the Project Manager of (international) clinical trials in order to coordinate all study-related activities.
  • Maintain TMF (eTMF, web study portal, M drive or paper in accordance with project specific procedures) and track collection of essential documents
  • Organize logistics of international study meetings
  • Translation of all types of Clinical Trial related documents from/into local language into/from English
  • Study feasibility assessments
  • Consistently complete and maintain Clinical Trial Management System (UBC Track, IMPACT or other) according to project specific requirements
  • Consistently complete all other project specific tracking tools
  • Consistently escalate issues found at the site in timely manner according to project specific requirements

 

 

 

Requirements:

 

  • Bachelor’s degree – Life Science preferred, or equivalent years of industry and monitoring experience (according to the local legislation)
  • Minimum of > 24 months active monitoring (with certification of previous experience, if requested according to the local legislation)
  • At least one Training Education File form signed by the LM ( on site monitoring visit/ central monitoring call)
  • AIMS training to mentoring on site co-monitoring visits/ central monitoring calls
  • Thorough knowledge of medical terminology
  • Good written and verbal communication skills
  • Consistently meets or exceeds metrics for quality trip reports and letters
  • Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation
  • Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable)
  • Thorough knowledge of ICH-GCP and UBC SOPs
  • Up to 80% travel

Please apply via apply@ubc.com

Apply for this job: Sr Clinical Research Associate

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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