Note: The job is a remote job and is open to candidates in USA. ERGOMED is a company focused on advancing medicine through clinical trials and safety studies. They are seeking a Senior Clinical Research Associate to perform monitoring visit activities and ensure the adequacy of investigational sites throughout the study period.
Responsibilities
- 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 conduct 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
Skills
- 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 in oncology or rare disease
- 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 nationally
Company Overview