PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients
Post: Clinical Research Associate II
Job Description:
The 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. Required to travel 60-80% on average.
Qualifications
Education and Experience:
- Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution
- Applicants with Respiratory, Asthma or COPD monitoring experience are particularly welcome to apply
- Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job (comparable to one year) or completion of PPD Drug Development Fellowship.
- 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
Candidate Profile:
Knowledge, Skills and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Customer focus
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Additional Information:
Location: New Delhi
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 15th April, 2013
Job Code: 109249
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