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Clinical Research Assistant

Covance 10/5/2018 12:19:39 PM
JOB ID: 24449 Category: Administration Clerical
Warsaw, Poland



Job Overview

Get ready to redefine what's possible and discover your extraordinary potential at Covance. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients—and your career.

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.

We are currently recruiting Clinical Research Associate to join our Sponsor's team in Warsaw, Poland. This is a regular full-time position.

Duties and Responsibilities:

* Act as contact for project team and study sites.
* Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
* Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
* Assist with the management of study supplies and organize shipments.
* Create, update, track, and maintain study-specific trial management files, tools, and systems.
* Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings).
* Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
* Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
* Provide input in writing Monitoring Conventions as assigned.
* Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
General On-Site Monitoring Responsibilities:
* Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
* Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors.
* Perform other duties as assigned by management.

Education / Qualifications

* Basic understanding of biology and biological processes.
* University/college degree (life science, 5 yrs is preferred), or certification in a related allied health profession from an appropriately accredited institution- Good organizational and time management skills.
* Good communication skills, oral and written.
* Exhibit general computer literacy.
* Works efficiently and effectively in a matrix environment.
* Fluent in local office language and in English, both written and verbal.


* One (1) or more years of Experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing).
* Basic knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred
* Ability to work with minimal supervision
* Works well independently as well as in a team environment
* Good planning and organization skills
* Good computer skills with good working knowledge of a range of computer packages
* Excellent verbal and written communication skills
* Ability to work within a project team
* Works efficiently and effectively in a matrix environment
* Experience of Microsoft Word and Excel
* Self-motivation with the ability to meet deadlines
* Detail oriented
* Process oriented
* Positive attitude and approach
* Interact with internal customers with professionalism and discretion
* Multi-tasking capability

Position Type: Full-Time

Location: Warsaw, POL - Poland


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).