Clinical Research Associate

Advanced Resource Managers; München; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading clinical research organization in Germany is seeking an experienced Clinical Research Associate to coordinate clinical monitoring and site management. This role involves ensuring compliance with FDA guidelines, conducting site visits, and mentoring junior team members. The position is offered on a 12-month contract, working 32 hours per week, and requires travel of 60-80%. Fluency in English and the local language is essential.

Qualifikationen

• Degree in a science related field or equivalent certification.
• Considerable clinical research monitoring experience.
• Demonstrated ability to evaluate medical research data.

Aufgaben

• Conduct site visits to assess compliance and manage documentation.
• Represent the client in the medical research community.
• Mentor and train junior clinical team members.

Kenntnisse

Clinical research monitoring

Expert knowledge of GCPs and FDA guidelines

Team building skills

Effective presentation skills

Fluency in English

Ausbildung

Degree in a science related field or equivalent certification

Jobbeschreibung

Are you an experienced 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 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.