To perform Site Selection, Site Initiation, Interim Monitoring Visits, Close Out Visits, EC Submission and Coordination, Coordination with Data Management & Query Resolution etc.

• Maintains timely and effective communication among team members and site staff. Keeps project leadership apprised of team issues. • Assures compliance with CFR, State regulations, ICH and GCP guidelines and INC Research and sponsor SOPs• Assumes responsibility for site management and site staff performance • Monitors all types of clinical trials. Participates in all types of site visits. Assures Principal Investigator (PI) integrity• Assures compliance with all protocol requirements. Assures effective patient identification and recruitment plan is in place. Assures timely reporting of AEs/ SAEs and Protocol Violations. Regularly performs Investigational Product (IP) accountability. Regularly reviews the status of contents of the site Regulatory Binder• Performs source document verification (SDV) according to contractual requirements• Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP). Assures timely and accurate completion of Data Clarification Forms (DCFs)• Completes and submits visit reports according to SOP/WI or sponsor requirements and requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. TCRs, patient enrollment, SAEs • Updates study and patient status information and serves as (CTMS) resource for PM/LCRA• Tracks Investigator payments/ milestones, if requested. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit• Prepares for and attends investigator’s meetings • Assists with the preparation of study start up materials and tools• Attends clinical monitoring staff meetings, project team meetings and clinical training sessions according to the project Communication, Monitoring and / or Training Plans