Clinical Trial Operations Specialist

Há 2 dias

Londrina, Paraná, Brasil beBeeClinical Tempo inteiro R$45.000 - R$60.000
Job Overview:

We are seeking a highly organized and detail-oriented professional to provide administrative and technical support to our project team in the capacity of Clinical Trial Coordinator.

The successful candidate will ensure audit readiness by reviewing files according to the schedule detailed in our standard operating procedures (SOP) and department guidance document.

They will also provide administrative support for site activation activities, aid in the development of the critical path for site activation, and represent our organization's personnel.

Additionally, they may utilize local knowledge, organizational systems, external site lists, and sponsor directives to develop and review site lists suitable for feasibility activities and provide local input into the site tiering process.

As a buddy during onboarding, they will provide training to new staff as needed.

Key Responsibilities:
  • Provide administrative and technical support to the project team
  • Ensure audit readiness by reviewing files according to the schedule
  • Provide administrative support for site activation activities
  • Aid in the development of the critical path for site activation
  • Represent our organization's personnel
Qualifications and Skills:
  • Education and Experience: High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • Knowledge, Skills and Abilities:
  • Ability to work in a team or independently as required
  • Good organizational skills and strong attention to detail
  • Demonstrated ability to effectively analyze project-specific data/systems
  • Strong customer focus
  • Flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and our organization's SOPs and WPDs
  • Good English language and grammar skills and proficient local language skills as needed
  • Good computer skills, proficient in MS Office and ability to obtain knowledge and master all clinical trial database systems
  • Ability to successfully complete our organization's clinical training program
  • Self-motivated, positive attitude and good interpersonal skills
  • Effective oral and written communication skills
  • Good interpersonal skills
  • Essential judgment and decision-making skills
  • Capable of accurately following project work instructions
  • Good negotiation skills
  • Independent thinker
  • Ability to manage risk and perform risk escalation appropriately

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