Perform all aspects of in-house site management in accordance with good clinical practices Conduct regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilitiesDocument and help follow to resolution, issues noted during site management contactsEscalate to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelinesServe as the primary study contact for sites Respond to ad hoc site requests for assistanceAssist sites with the resolution of outstanding data queriesProvide ongoing site training Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsorPlay an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines

Provide technical support to the project team. Coordinate non-clinical responsibilities of project administration as applicable to the client contract.* Review regulatory documents for proper content.* Perform PPD investigator file reviews and logging of outstanding issues in project related tracking tools.* Liaise with monitor and investigative sites to resolve outstanding regulatory issues identified* Disseminate study related information, including project tracking updates to Clients, clinical study teams and other PPD departments* Assist with the identification of potential investigators and development/distribution of initial protocol packets* Create meeting agendas and minutes* Coordinate team conference calls and distribution of meeting minutes

Main functions: follow up projects, data bases management, contact sponsors, finding Business opportunities, management and development of Standard Operation Procedures, schedule and coordinate visits of sponsors in conjunction with key-business-people, coordinate activities for submission of protocols to COFEPRIS, submission of amendments and Sanitary Import Permits, review of project feasibility studies, coordinating delivery of inputs for Clinical Trials, sponsor visits, preparation of Quotations and Contracts, drafting confidentiality agreements. Coordination of activity times in each of the areas involved to define delivery times to customers. Handling and storage of study documentation: Agenda of Monitoring Activities, Amendments, Research Protocols, Monitoring Reports, Informed Consent, Clinical Report, etc. Care and follow up monitoring visits.