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.*