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Job Details

Lead Clinical Research Associate

Company: United BioSource Corporation.
Location: London, United Kingdom
Reference: REQ20011947
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Brief Description:  Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs; provides clinical project oversight and support the PM team as described under Specific Job Duties and/or according to site management and monitoring plans. ...

Requirements:

Brief Description:  Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs; provides clinical project oversight and support the PM team as described under Specific Job Duties and/or according to site management and monitoring plans.

Requirements:

  • Bachelor’s degree – Life Science preferred or equivalent industry and monitoring experience
  • Minimum of > 24 months active monitoring
  • Knowledge of medical terminology
  • Good written and verbal communication skills
  • Displays leadership, organizational and interpersonal 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
  • Proven skills with CTMS, EDC, Outlook, Excel and other basic computer software and client specific systems (if applicable)
  • Thorough knowledge of ICH, GCP,  and UBC SOPs
  • Up to 50% travel

Specific Job Duties:

  • Thorough knowledge of sponsor specific project requirements, protocol and timelines
  • Contact with CRAs to have a thorough knowledge of the local country laws applicable to clinical trials/ observational studies and ICH GCP.
  • Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines
  • Reviews and approves Monitoring Visit/ Remote monitoring Reports and Letters within UBC and/or Sponsor timelines
  • Maintains at least one active site per study assignment
  • Assists with project specific training
  • Ensures appropriate CRA visit scheduling per protocol; tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks
  • Maintains and tracks Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines
  • Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
  • Attends client and project team meetings – assists with preparation, content and leading of meetings as required
  • Assists with reporting on monitoring activity to include status report, co-monitoring and trip report metrics
  • Acts as back-up for Project Manager and may be primary contact for UBC/Sponsor interaction
  • Coordinates EDC data entry, if applicable, and DCF resolution
  • Coordinates site assignments in conjunction with Project Manager and Functional Manager; assists with other project specific tasks as delegated by Project Manager
  • Consistently completes travel scheduling in accordance with project specific and UBC guidelines
  • Attends project team meetings, departmental meetings as required.
  • Review to ensure consistently accurate 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 with minimal corrections required and direct as appropriate.
  • Enters/ review site visits, confirmation/follow-up letters and site monitoring reports into CTMS
  • Review to ensure consistently accurate Call Log or Telephone Contact Report detailing communication with sites in a timely manner and direct as appropriate.
  • Review Regulatory Binder to ensure completeness.
  • Consistently completes expense reports within UBC timelines and guidelines
  • Consistently completes SOP review and documentation within requested timelines
  • Consistently completes sponsor specific training and documentation within requested timelines
  • Review/ ensure that CRA’s consistently complete sponsor specific training and documentation within requested timelines
  • 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
  • Creates and maintains clinical project documents with Project Manager oversight and finalizes with appropriate team review (PM, Sponsor, etc.)
  • Assists management team with one to one meetings or JDE timesheet approval as delegate.
  • Review of translations, if applicable
  • Local coordination of national and international studies
  • Review of the Preparation, submission and tracking of ethics committee and other regulatory applications by the CRA
  • Review and direct the Contract negotiation activities  with the hospitals and local R&D Departments
  • Review to ensure that the Maintenance of  TMF, project files is correct, and that the tracked collection of essential documents is accurate
  • Organize logistics of international study meeting
  • Study feasibility assessments review
  • Complete UBC Track according to project specific requirements
  • Complete all other project specific tracking tools related to this role
  • Review to ensure that CRAs comply with all other project specific tracking tools

Apply for this job: Lead 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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