Senior CRA
ICON
Warsaw
‎11 godz. temu

As a Senior Clinical Research Associate (home or office based) at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - III, ensuring adherence to applicable regulations and principles of ICH-GCP.

We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

The role

Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation

Submission of protocol, consent documents for ethics / IRB approval and assist in preparing regulatory submissions as requested

Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required

Managing sponsor generated queries efficiently and responsible for study cost effectiveness

Dependent on level of experience you may assist in training and mentoring less experienced CRA's and / or manage CRA's working on international projects

What you need

18 months+ of monitoring experience in phase I-III trials as a CRA

Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data

Native local language and English is a must

Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner

Ability to produce accurate work to tight deadlines within a pressurized environment

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