Senior Clinical Research Associate (South East)

ErgomedJacksonville, FL
Hybrid

About The Position

The Senior Clinical Research Associate (CRA) will perform on-site or remote monitoring visit activities including Pre-Study, Initiation, Interim, and Close-Out visits. This role ensures that investigational sites have adequate facilities and staff to conduct the study. The CRA will identify investigators, verify their qualifications, resources, facilities, equipment, and staff throughout the study period. Additionally, the role involves training investigational site staff, supporting regulatory and/or EC submissions when applicable, and participating in mentoring/training new staff through 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 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

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.

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
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