ISSC Associate - Home or Office Based

Stevenage, Hertfordshire (GB)
07 May 2019
03 Jun 2019
Full Time
Contract Type
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.