ICON Clinical Research Study Start Up Associate in Sofia, Bulgaria

Study Start Up Associate with ICON Clinical Research

  • Homebased in Bulgaria*

This is an exciting opportunity to work within a fast paced, world class CRO in a dedicated, passionate team operating within a collaborative work culture where accountability and integrity are at the heart of our organization.

The key purpose of the Study Start Up Associate position is to co-ordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials. The role also prepares, reviews and submits applications to Ethic /Regulatory Authorities and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

Role responsibilities include, but are not limited to:

  • Develop and finalize Country Specific SIS/ ICFs.

  • Prepare and finalize Country Specific xml files (if applicable for region).

  • Perform independent quality review of submission packages.

  • Collect and maintain current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON information system.

  • Responsible for the translation and co-ordination of translations for documents required for submission (if applicable for region). This included also the drug labels.

  • Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system.

  • Copy and route incoming correspondence, internal documentation, etc., as appropriate.

  • Assist and provide support to the Study Start Up Lead to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.

  • To succeed you will need:*

We welcome applications from candidates who hold a Bachelor’s Degree in Life Sciences or a related field. You will have some prior exposure to clinical Study Start Up / Site Activation activity . You will also have familiarity with regulatory guidelines and industry knowledge.

  • What’s Next?*

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

  • ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*