Clinical Research Monitor(CRA) sostituzione maternità

Basic qualifications:

Education required: 
Degree in life sciences, nursing or other health related disciplines.

Experience:

Two (2) years Clinical Research experience.

Preferred qualifications:

One (1) year of Clinical Research monitoring preferred.

• Capable of clearly and effectively communicating verbally and in writing

• Excellent interpersonal skills

• Experience working in a team/matrix environment requiring strong working relationships

• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously

• Ability to work in a fast paced environment

• Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction

• Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands

• High attention to detail and accuracy

• Excellent problem solving skills

• Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)

• Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)

• Business knowledge or experience with the medical / healthcare industry

• Class III medical device and/or phase II, III and IV pharmaceutical experience

• Experience of conducting clinical research activities in a regulated environment

• Proficient knowledge of medical terminology

• Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)

• Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

• Ability to travel up to 80%.

• Travel with colleagues and manager as requested.

• May require international travel.