Clinical Research Associate

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About the department

Clinical department of Novo Nordisk in Ukraine conducting clinical trials II-IV phases according to Good Clinical Practice and local regulatory requirements.

The job

Clinical Research Associate performs all required activities to ensure appropriate monitoring of investigator sites and trial execution in accordance with ICH GCP guidelines, applicable SOPs and local regulations.

Qualifications

You hold University degree (life science or medical, pharmaceutical preferred).

You have minimum 1 year of experience in on-site monitoring; your experience in local study management will be a strong advantage.

Knowledge of GCP and regulatory compliance guidelines for clinical trials.

Experience in preparing documents for submission to IRBs/IECs and Regulatory Authorities.

Familiarity with clinical trials designs and methods.

Computer literacy (e.g. EDC, IMPACT, MS Office, etc.).

Excellent verbal and written communication skills in English;

Willing and able to travel (up to 50% of the time).

Excellent organizational and time management skills as well as working flexibility.

Main responsibilities

Prepare trial documents for submission to IRBs/IECs and Regulatory Authorities.

Perform sites feasibility and investigators' selection.

Communicate with sites for ensuring adequate enrolment rate.

Perform clinical on-site monitoring activities (source data verification and review, drug accountability, data collection etc.)

Prepare and submit Monitoring Visit Reports within defined timelines.

Maintain and update study related documentation from CRA's area responsibility.

Manage and complete reporting of Serious Adverse Events happened within Clinical Trials on site.

Provide study related training for Investigators on the routing practice.

Update central data base in International Management Package for Administration of Clinical Trials (IMPACT) regularly.