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Senior CRA - Client dediated, Copenhagen

Covance 10/4/2018 5:01:48 AM
JOB ID: 24403 Category: Clinical Monitoring
Copenhagen, Denmark

   

 

Job Overview

Covance is actively recruiting a Senior CRA in Denmark, ideally to be based in the Copenhagen area. This is a full time Client Dedicated role so the selected candidate will only be working on studies from a single sponsor!

Key Duties:

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, with or without guidance; liaise with vendors; and other duties, as assigned

Responsible for aspects of registry 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

+ Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
+ Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management

+ Provide coverage for clinical contact telephone lines, as required

+ Update, track and maintain study-specific trial management tools/systems

+ Generate and track drug shipments and supplies, as needed

+ Track and follow-up on serious adverse events as assigned

+ Implement study-specific communication plan as assigned

+ Attend investigators' meetings, project team meetings and teleconferences, as needed

+ Assist Senior CRA in managing investigator site budgets

+ Perform other duties as assigned by management

For more information please contact Andy Smith on +44 (0)1635 253 724 or send your CV to andy.smith@covance.com

Education / Qualifications

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

and

A minimum of six months on-site monitoring (preferred)

Valid Driver's License

Experience

* Field based, home office but willing to come into the Copenhagen office, when required
* Previous monitoring Experience in clinical trials, minimum 2 years
* Proven skills in site management including site performance and patient recruitment
* Excellent soft skills (include oral and written communication skills; computer literacy; works effectively in a matrix multicultural environment)
* Good organizational and time management skills, able to work highly independently and be a team player
* Flexibility, expected travelling ~2-3 days/week
* Customer focus and right mind-set to meet client's needs and skills in building relationship with customer.
* Ability to set up priorities and handle multiple tasks simultaneously in changing environment
* Fluent in English (verbal and written)
* Location strong preference near Copenhagen


Position Type: Full-Time

Location: Copenhagen, DNK - Denmark



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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).