• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and overall study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. • Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process. • Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s). • Assists in preparing sites for audits and in resolving audit action items. • Supports sites during audits remotely and/or onsite as needed. • Participates in meetings with prospective clients. • Supports training and mentoring of CRAs during remote and onsite visits. • Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents. • Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development. • Supports Core Laboratory management and may serve as the primary contact. • Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks. • Performs and summarizes literature searches. • Registers trials on Clinicaltrials.gov