Qualifications

Clinical Research Associate, St Petersburg

The 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 60-80% 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

Please contact Pontus Larsson on +46 (0) 8 40 309 983, or email on pontus@proclinical. com for more information