Careers at ESTERN Medical


Business Title

Home Base Clinical Research Associate Level II & III

Requisition ID

EM-HB-SR-CRA-1005

Job Category

Home Base Clinical Research Associate

Locations

*Mexico / *Chile / *Colombia / *Argentina / *Peru /*Brazil.

Job Description

Job Summary:

Description

The experienced Senior 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/EMEA/LA local guidelines, local regulations and ESTERN Medical 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 ESTERN Medical 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

Requirements:

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 Significant clinical research monitoring experience (comparable to at least 3-5 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.

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/EMEA and local LA 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, Spanish or Portuguese language and grammar skills

Effective presentation skills

ESTERN Medical is an Equal Opportunity Employer