**Company Description** PSI is a leading Contract Research Organization with more 30 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 indications. **Job Description** * Coordinates investigator/ site feasibility and identification process, as well as study startup. * Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. * Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. * Manages Monitors in the query resolution process, including Central Monitoring observations. * Coordinates safety information flow and protocol/process deviation reporting. * Performs clinical supplies management with vendors on a country and regional level. * Ensures study\-specific and corporate tracking systems are updated in a timely manner. * Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. * Coordinates planning of supervised monitoring visits and conducts the visits. * Manages the project team in site contracting and payments. * Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. * Ensures ongoing evaluation of data integrity and compliance at a country/regional level. * Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. * Oversees project team in CAPA development and implementation. * Coordinates project team in process deviations review, management and reporting. * Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. * Provides project\-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. * Delivers trainings and presentations at Investigator Meetings. * Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. * Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. * Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. * Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. * Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. * Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. * Ensures data integrity and compliance at a site level. * Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. * Conducts project\-specific training of site Investigators. * Supports preparation of draft regulatory and ethics committee submission packages. **Qualifications** * Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. * Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. * Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices. * Experience with all types of monitoring visits in Phases I\-III. * Strong experience in Oncology preferred. * Experience in CAR\-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. * Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. * Full working proficiency in English. * Proficiency in MS Office applications. * Ability to plan, multitask and work in a dynamic team environment. * Excellent Communication, collaboration, and problem\-solving skills. * Ability to travel up to 65% (depending on project needs). * Valid driver’s license (if applicable). **Additional Information** Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.