Ref #: 25764

Employment type: Permanent - Full-Time

Location: Home Based, Germany.

Posted: 14-Jan-2021

Description

Summary:

We are growing our partnership with one of the top global pharmaceutical companies. If you are seeking a career where you can truly make a difference, using innovative science and technology to reimagine medicine to improve and extend people’s lives, then here is your chance.
DOCS is hiring Clinical Research Associate’s (m/w) to become part of this incredible team. If you are a CRA anywhere in Germany willing to work home based and open for a new challenge, we would like to get to know you.


Key responsibilities:
• Perform site qualification, site initiation, and closeout visits, ensuring regulatory and protocol compliance. Visits may be on-site or remote.
• Generate queries and manage resolutions with site personnel.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required study documents as per SOPs and Study Monitoring Plan.
• Perform investigational product accountability as per the protocol and Study Monitoring Plan.
• Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
• Act as primary liaison with site personnel.
• Management and collection of site's study regulatory documents.
• Enter data into tracking systems as required.
• Assist and support audit preparation and CAPA implementation.
• AE/SAE and expedited reporting and management.
• Travel frequency of up to 60%


Requirements

• Degree in life sciences, pharmacy preferred.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Proven experience in on-site monitoring of clinical studies is a must
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus.
• Proven ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.
• Ability to travel as necessary up to 70% depending on assignment. Overnight and occasional weekend travel may be required.



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.

Would you like to know more? Please submit your CV via www.docsglobal.com or timo.kindermann@docsglobal.com. We are looking forward to your application.
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