ISSC Associate - Home or Office Based
- Experience Level
- Entry level
Iqvia Biotech's ISSC team are expanding the Start Up side of their division
• Supports the ISSC lead or representative to provide updates during weekly client teleconferences and internal team meetings, as required.
• Participates in the drafting of the feasibility questionnaire for a study.
• Assists in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to ascertain interest and to meet study timelines.
• Participates in the review and negotiation of the CDAs according to country specific requirements.
• Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process at the site.
• Supports sites to answer any questions required for their local IRB/ethics committee submissions.
• Depending on the country, may support the review and negotiate Informed Consent Forms and follows up with sites and sponsors accordingly.
• Contacts sites directly, or through local representative (country dependent), as required to resolve issues before IRB/ethics committee submission and final review.
• Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
• Notifies Regulatory Affairs department when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns.
• Adheres to study timelines, documents/escalates study challenges, and communicates updates to Project Manager and ISSC Lead/Management.
• Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.
• Performs other duties as required.
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