Are you an experienced Senior Clinical Research Associate with considerable clinical research monitoring experience? Are you based in Germany and looking for a new contract role? If so, we are keen to hear from you!
Our leading CRO client is recruiting for a Senior CRA to be based in Germany, performing and coordinating all aspects of the clinical monitoring and site management process.
This position is offered on a 12 month contract basis initially, working 32 hours per week.
Description:
* Work in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures
* Conducts site visits to assess protocol and regulatory compliance and manages required documentation.
* Responsible for ensuring that data will pass international quality assurance audits.
* Represent our client in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel.
* Will assist project manager or clinical team manager on assigned projects and will take a lead role where required.
* Will support the line manager to mentor, train and contribute to the development of junior clinical team members.
* Required to travel 60-80% on average.
Education and Experience:
* Degree in a science related field or, a certified health care professional, or equivalent certification/licensure from an appropriately accredited institution.
* Considerable clinical research monitoring experience with a demonstrated high level of expertise in all aspects of clinical monitoring.
* Expert clinical monitoring skills.
* Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures.
* Skills to mentor and train other monitors in a positive and effective manner.
* Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology.
* Proven flexibility and adaptability.
* Excellent team player with team building skills.
* Effective presentation skills.
* Ability to work independently as required.
* Ability to utilize problem-solving techniques applicable to constantly changing environment.
* Fluency in English and in the country's native language.
* Valid Driver's License.