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Clinical Research Associates

CV MARKET´S CLIENT

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Darba sludinājuma numurs 181195

Darba sludinājuma numurs

181195

Job Description


Clinical Research Associates



We are currently looking for a talented Clinical Research Associate II to work for us in
the Co-source department as our sponsor, a well-known pharma company, is
currently expanding their Clinical Operations team. The role is full-time/permanent and
the successful candidate will be office-based at Client's in Riga.

Summary:

This is a CRA position available to work within our Phase II-IV CoSource division
directly with pharmaceutical company. As an experienced CRA you’ll be involved in initiation,
routine & close out visits concentrating on sites in Latvia.

Requirements:


    • Ability to monitor Clinical study sites independently according to protocol
    monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Excellent understanding of Serious Adverse Event reporting
    • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Germany
    • Previous experience of leading/managing a CRA team
    • Experience of reviewing CRA trip reports
    • Fluency in speaking and writing both English and German
    • Oncology experience
    • Degree in life sciences OR equivalent experience in clinical monitoring
    • At least 3-4 years experience in clinical monitoring, oncology experience preferred


Duty Highlights:

As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

Responsibilities include:

    • All aspects of site management as prescribed in the project plans
    • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
    • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
    • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
    • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
    • Management of administrative duties connected with assigned protocols


Why Covance?

At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

We welcome your application and believe this decision may be the most rewarding career move you will ever make!

Please click here to apply >>> Apply link



Location:
Rīga
Job type:
full-time, employee
Expiration date:
2018. gada 10. marts
Published:
2018. gada 9. februāris

CV MARKET´S CLIENT

We are currently looking for a talented Clinical Research Associate II to work for us in
the Co-source department as our sponsor, a well-known pharma company, is
currently expanding their Clinical Operations team. The role is full-time/permanent and
the successful candidate will be office-based at Client's in Riga.