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