Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period
Trains investigational site staff as necessary
When applicable, supports preparation of regulatory and / or EC submissions
Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance
Requirements
College/University degree in Life Sciences or an equivalent combination of education, training & experience
Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials
Full working proficiency in English
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel
Benefits
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Clinical Research Associate II at ERGOMED | JobVerse