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Education and Experience:
- University 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 (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring
- Fluency in English and in the country's native language
- Valid Driver's License where applicable
- In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered
Knowledge, Skills and Abilities:
- 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
- Excellent oral and written communication skills
- Strong customer focus
- Excellent interpersonal skills
- Excellent organizational and time management skills
- Strong attention to detail
- 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
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skillsIf you are interested in this career opportunity, please submit your CV in English.
PPD is an Equal Opportunity Employer
The (Senior) Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process 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. Represents PPD 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
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 15,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com