Clinical Trials Coordinator: Regulatory & Site Operations

Brigham and Women's Hospital

Boston (MA)

Presencial

USD 34 000 - 54 000

Tempo integral

Há 9 dias

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Resumo da oferta

Mass General Brigham is seeking a trial support professional to ensure each project complies with the protocol, GCP, regulatory requirements, and sponsor standards. You will work independently to support one or more clinical trials and handle day-to-day project activities onsite.

The role requires a Bachelor's degree and 1–2 years of research experience, preferably with EDC/CTMS. Strong organizational and communication skills are essential for matrix environments and multitasking.

Qualificações

  • Bachelor's Degree required in a related field.
  • Research-related experience 1-2 years, or familiarity with EDC and CTMS systems (2-3 years preferred).
  • Strong organizational and communication skills with the ability to work autonomously.

Responsabilidades

  • Identify and initiate communications with sites to obtain relevant documents.
  • Review site regulatory documents for completeness before submission.
  • Advise sites on protocol conduct and issue resolution.
  • Update internal databases, tracking systems, and study files.
  • Prepare materials for internal and external meetings; draft agendas and minutes.
  • Support trial processes and reports with the Project Manager.
  • Promote policy/process improvements and ensure SOP compliance.

Conhecimentos

Organizational Skills
Written & Verbal Communication
Accountability
Matrix Communication
Multitasking

Formação académica

Bachelor's Degree Related Field

Ferramentas

EDC
CTMS

Descrição da oferta de emprego

Mass General Brigham is seeking a trial support professional to ensure each project complies with the protocol, GCP, regulatory requirements, and sponsor standards. You will work independently to support one or more clinical trials and handle day-to-day project activities onsite.

The role requires a Bachelor's degree and 1–2 years of research experience, preferably with EDC/CTMS. Strong organizational and communication skills are essential for matrix environments and multitasking.

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