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Job Details

Clinical Research Associate - 2

Company: Chiltern
Location: Home-based Anywhere in Canada
Reference: 9999
Closing Date: 15 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

The CRA 2 is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to a CRA 2 shall reflect his/her experience and the level of contribution, which he/she can make to that project.

Requirements:

Job Background

PREFERRED SKILLS:

  • A BSc or BA degree in a biomedical or related life science, or nursing qualification
  • Previous CRA experience within clinical research of approximately 18 months
  • Good clinical knowledge with an understanding of medical terminology
  • An understanding of the basics of physiology and pharmacology
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
  • Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English.
  • Experience working in a team environment under time and resource pressures
  • Understanding of the principles of ICH GCP and regulatory requirements
  • Experience of the clinical research process and terminology
  • Experience using a clinical trial management system

PRINCIPAL ACCOUNTABILITIES AND RESPONSIBILITIES

Clinical Monitoring Activities:

  1. To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs.
  2. To identify potential centres for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required.
  3. To ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies
  4. To be proactive in all dealings with study sites. To ensure that all study related communication including e-mail is tracked, printed and filed as required.
  5. To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA.
  6. To deal with local or central laboratories in order to ensure adherence to the protocol.  To ensure that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.
  7. To provide appropriate support for the preparation, submission/notification of local regulatory approval if required for local country requirements.
  8. To distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits.  To ensure that sites have sufficient supplies to continue recruitment.
  9. To provide assistance in the production of Case Report Forms and protocol design.
  10. To track CRFs collected during monitoring visits to data management.
  11. To liaise with data management regarding data flow and data query processing.
  12. To ensure that the interim safety reports are provided to EC/IRBs as per country requirements.
  13. An understanding of the purpose of Chiltern's Clinical Project Management System (CPMS), how to use it, and how to navigate within the different sections. The ability to enter weekly details on Chiltern’s Project Management System.
  14. To assist the Project Manager in the production of Status Reports.
  15. To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the LCRA and Project Manager.
  16. To raise invoice requests for investigator payments in accordance with Investigator/Hospital/Pharmacy agreement terms, to maintain the site financial tracking, producing a list for pending investigator payments and producing payment requests for Chiltern International as appropriate for local country requirements.
  17. To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
  18. To be accountable for ensuring that all relevant study documentation is present for study sites.
  19. To undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site file preparation) as appropriate, as assigned by the Project Manager and LCRA.
  20. To document all study activities including investigator contacts using relevant forms.
  21. To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study.
  22. To assemble files and ensure documents for the sponsor file accurately reflect the progress of the study.
  23. Assist in the organization of meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
  24. To use all reasonable endeavours to work precisely according to schedules and timelines, established by the Sponsor and Project Manager for the conduct and completion of the study.

 



Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

TBD

Position Type

Permanent
Full Time

Contact

Email Carmen Guerra - Carmen.Guerra@Chiltern.com
+1 512 987 0052

Apply for this job: Clinical Research Associate - 2

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
USA

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