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Job Details

CRA (Level II)-135705

Company: PPD
Location: Europe, Middle East & Africa-Bulgaria-Sofia
Reference: 135705
Closing Date: 10 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

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. ...

Requirements:

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 and/or may assist in the mentoring and training of junior clinical team members. Required to travel 80% on average.

Qualifications

Education and Experience:
  • University degree in a science related field or a certified health care professional or equivalent certification/licensure from an appropriately accredited institution
  • Significant clinical research monitoring experience (comparable to 3 years) that provides the required knowledge, skills and abilities and experience mentoring or training others
  • Fluency in English and in the country's native language
  • 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
  • Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
  • Ability to mentor and train other monitors in a positive and effective manner
  • Ability to evaluate medical research data and proficient knowledge of medical terminology
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Strong customer focus
  • Excellent interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Excellent team player with team building skills
  • Ability to work independently as required
  • Ability to utilize problem-solving techniques applicable to constantly changing environment
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English language and grammar skills
  • Effective presentation skills
PPD is an Equal Opportunity Employer

Apply for this job: CRA (Level II)-135705

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Tel:  +44 1223 374100
Website:  Visit Our Web Site

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