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.
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.
This position has no direct supervisory responsibilities
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)
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
A minimum of one 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.
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: 136073
End Date: 25th November, 2016
To apply online, Click here.