Ref #: 25260

Employment type: Permanent - Full-Time

Location: Germany

Posted: 17-Nov-2020

Description

DOCS Global is currently looking for medical device technicians and candidates with strong laboratory experience to join their growing diagnostics team in Germany.

This is a fantastic entry opportunity for any candidate with a solid scientific background to start their career in Pharma and join one of the leading organizations in the field.

The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

Responsibilities include but are not limited to:
- Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;

- Validating product performance claims;

- Supplying data for critical Regulatory submissions;

- Defining the functional and clinical utility of investigational products, and obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.

The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions.


JOB FUNCTIONS/RESPONSIBILITIES


- Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout.

- Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.

- Interfacing with cross functional staff to support post launch activities.

- Reviewing cases with investigators to resolve discrepancies. Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and procedures


EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS


- Excellent oral and written communication skills
- Excellent planning, organizing, and interpersonal skills
- Ability to work independently, make sound decisions, and to analyze and solve problems
- Demonstrated experience in computer skills to include Microsoft Office, and basic templates
- Medical laboratory experience preferred
- Up to 2 years of experience in CRA IVD role preferred but not required


EDUCATION REQUIREMENTS


Minimum :

- Bachelor's degree in science or relevant field.
- Medical technology degree preferred, but not required if R&D background is adequate

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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