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Clinical Research Associate II

Covance 5/16/2019 5:51:14 AM
JOB ID: 30351 Category: Clinical Research Associates
Munich, Germany

   

 

Job Overview

Covance is serching for the CRA II for multiple sponsors to be home based in Germany

You have a great opportunity to be a part of exceptional teams and have a chance to work for multiple studies for different sponsors.

Your main responsibilities:

* Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
* Responsible for all aspects of site management as prescribed in the project plans
* General On-Site Monitoring Responsibilities
* Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
* Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
* Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
* Monitor data for missing or implausible data
* Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy

* Travel, including air travel, may be required and is an essential function of the job.
* Prepare accurate and timely trip reports
* Responsible for all aspects of registry management as prescribed in the project plans
* Undertake feasibility work when requested
* Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
* Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
* Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
* Assist with training, of new employees, e.g. co-monitoring
* Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Education / Qualifications

* University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
* Minimum of 2 years of Clinical Monitoring Experience .

Experience

We require:

* Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Good planning, organization and problem solving abilities
* Ability to work with minimal supervision
* Good communication and interpersonal skills
* Good analytical and negotiation skills
* Computer competency
* Fluent in local office language and in English, both written and verbal
* Works efficiently and effectively in a matrix environment


Position Type: Full-Time

Location: Munich, DEU - Germany



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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 www.gettinghired.com 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).