Ref #: 24594

Employment type: Permanent - Full-Time

Location: Austria - Home Office possible

Posted: 12-Oct-2020

Description

DOCS is partnering with one of the most successful global pharmaceutical companies to support them in developing new drugs in critical areas to increase health and quality of live all over the world.
To accomplish this we are currently looking for an experienced Clinical Research Associate (m/w).


Responsibilities:

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with related SOP, applicable regulations and the principles of ICH –GCP and with applicable regulatory requirement.

The monitor has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents.


The responsibilities of the Clinical Research Associate include, but are not limited to:

• Act as the main line of communication between the sponsor and the investigator;
• Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout;
• Responsible for the safety and proper conduct throughout the trial;
• Verifying that the investigator follows the approved protocol and all GCP procedures;
• Verifying that source data/documents and other trial records are accurate, complete, and maintained;
• Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs;
• Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience;
• Strong knowledge in ICH-GCP;
• Ability to review and evaluate clinical data;
• Computer literacy desirable;
• Professional use of the English language; both written and oral;
• Good oral and written communication skills;
• Due to the nature of this position it will be required for the employee to travel;


Education & Experience

• Life Science degree or equivalent
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company) of 2+ years (onsite monitoring interventional studies phases I-III of different indications)
• Experience in early phases and one or more of the following indications are a plus: Dermatology, CNS, Crohn’s, Respiratory.
• Attention to detail, organizational skills, time management & prioritization, proactive personality
• Relationship management & influencing skills
• Proficiency in English and German
• Good working knowledge of common software packages
• Flexibility and Team skills


What is offered:

• 100% Home Office
• Permanent contract
• Friendly work atmosphere in a great team
• Compensatory time-off
• Contribution to pension scheme
• Travel time = work time


Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested?

Please submit your CV to roger.bravomendez@docsglobal.com or apply via www.docsglobal.com. We are looking forward to your application !
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