Company DescriptionPSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic DescriptionThis is a home-based position in Bogotá, CO to exclusively manage USA clinical research activities. 1. Site ManagementSupervises and coordinates the exchange of data, documents and other project relevant information between investigative sites, the project team, the sponsor,
and central / regional vendorsCoordinates the process of IRB/IEC and CA submissions and notificationsMay coordinate financial and contractual tasksCoordinates and assists with preparation and follow-up of site, and systems audits and inspections2. Other CommunicationExchanges data, documents, and other information with the project team, other departments, vendors and customers Coordinates and supervises communication within the project teamCoordinates and assists with organization of project meetingsPrepares draft agendas for, and minutes of, project meetingsCoordinates preparation, attendance and follow-up of Investigators´ Meetings3. TrainingConducts on-the-job coaching of Clinical Trial AdministratorsCoordinates, conducts and monitors compliance of project-specific training of the study team members4. Document ManagementMaintains Trial Master File (TMF)Performs regular TMF QC for completeness and accuracy, and prepares TMF checklistsAssists in preparation and follow-up of TMF auditsCoordinates preparation, distribution, and update of Onsite Study Files (OSF) and OSF checklistsSupervises and coordinates translations5. Safety ManagementCoordinates the safety information flow within the project team, and between the project team and investigative sites 6. Compliance MonitoringMay perform IP-Release Enabling Document QCsParticipate in establishing and supervising in-process controls7. Project ManagementMay administratively coordinate clinical supplies (including medication) order, receipt, inventory store, distribution, return/recall and reconciliationAssists with preparing draft newsletters, progress reports and project plansReviews, coordinates and maintains study-specific and corporate tracking systemsMay be assigned other project management tasks8. Project Assignments May be assigned a Project Coordinator role within a project9. Corporate/Departmental AssignmentsProvides administrative assistance with feasibility researchMay be involved in the development of practices and training initiatives related to project administration at a regional levelQualificationsCollege or university degree or an equivalent combination of education, training and experience.Minimum 12 months´ experience as a Senior Clinical Trial Administrator or a similar position in clinical research.Proficient use of English and Spanish.Excellent communication skills.Additional InformationThis is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.