.**BASIC FUNCTIONS**:Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A SSUS II may be assigned to one or more start-up projects, and typically is able to work independently on a project with mínimal supervision.**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:- Provides updates during weekly client teleconferences, client meetings, and internal team meetings.- Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.- May provide a role in the coordination of the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.- May support ISSC Lead/Manager in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template for a study.- May distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaire to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.- May review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required.- Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process.- Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.- Supports sites to answer any questions required for their local IRB/ethics committee submissions.- Serves as IQVIA Biotech liaison with CEC/central IRBs/REBs/ECs, as applicable.- May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.- Contacts sites directly, or through local representative (country dependent), as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.- May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.- Liaise with legal and internal team to secure authorization of site contracts.- Coordinate document translations required for CEC/EC submissions, as needed