Vacancy for Clinical Research Associate at PPD Pharmaceutical
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 :
The Sr. 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. May assist project manager or clinical team manager on assigned projects. Required to travel 60-80% on average.
Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution Previous experience as a clinical research monitor (comparable to 2+ years) that provides the required knowledge, skills and abilities 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: Effective clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures Effective oral and written communication skills, with the ability to communicate effectively with medical personnel Strong customer focus Effective interpersonal skills Strong attention to detail Effective organizational and time management skills 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 Working Conditions Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. Frequently drives to site locations. Frequently travels (60-80% of time) domestically with extended overnight stays. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to fluctuating and/or extreme temperatures on rare occasions. Physical Demands Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Experience : 1-5+
Qualification : B.Sc
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th July, 2019
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