PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
With offices in 45 countries and more than 11,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
Western Region includes: AZ, CA, CO, HI, ID, MN, NV, NM, OR, UT, WA, WY
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.
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
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
PPD is an Equal Opportunity Employer
- CRA, Clinical Research Associate, monitor
Monster - 13 months ago