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
Job Description:
Basic Purpose and objective:
Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and SOPs. 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 the company in the global medical research community and develops and maintains collaborative relationships with investigational sites.
Position scope:
Serves as a primary contact with individual investigational sites that conduct clinical trials. Successful site management contributes directly to operational objectives, which in turn have an impact on project profitability. Goal is to deliver clean CRFs from an ICH GCP and SOP/WPD compliant process on time and within budget.
Supervisory responsibilities:
This position has no direct supervisory responsibilities
Candidate Profile:
Qualifications:
Bachelor's or higher graduate degree in a science related field, licensed or certified health care training or equivalent experience
Valid driving license (where applicable)
Valid passport
Skills and knowledge:
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail
Basic computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area knowledge and medical terminology preferred
Ability to work in a team or independently as required
Ability to travel and spend 60 to 80% of working week at site
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Experience:
A minimum of 3 - 7 year experience as a Clinical Research Associate / monitor or in a health sciences field / clinical research setting is preferred, although some trainee positions are available.
Additional Information:
Experience: Min. 1 Years
Location: Mumbai, Gurgaon
Education: B.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 136600
End Date: 30th January, 2017
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