01Requirements
Bachelors Degree in a life science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
Prior clinical research experience with a minimum of 2 years on site clinical monitoring.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Good therapeutic area knowledge and understanding of medical terminology by virtue of past training
of a CRA
Ability to attain and maintain a working knowledge of FDA and/or local country regulation and
guidelines, ICH GCPs and PPD procedural documents
Ability to successfully complete PPDs Clinical Foundation Training Program (CFP)
Highly effective oral and written communication skills with the ability to communicate effectively with
project team members
Excellent organizational and time management skills
Ability to work in a team or independently or as home based, as required
Ability to write clinical monitoring visit reports, review or approve them and interpret the information
captured in clinical monitoring visit reports
Ability to extract pertinent information from protocols, electronic study data systems, CTMS,
dashboards and assess risk at site level through interpretation of all these data
Excellent English language and grammar skills
Ability to mentor junior team members, as needed
Working Conditions and Environment:
Work is performed in an office.
Exposure to electrical office equipment. .
