PSI CRO AG

Research Analyst

• 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.

Lead Clinical Research Associate

Manager

• Responsible for operations, communication, and development of strategic site partnerships
• Develops global enrollment and retention solutions to increase patient screening, randomization, and compliance
• Builds and manages patient engagement service offerings and associated costs for global bids, including vendor and in-house resource allocation
• Designs and implements patient engagement assessments for awarded studies, focused on impact measurement, analysis, and mitigation planning
• Participates in scientific conferences, meetings, symposia, etc. to collect information on patient access and diversity
• Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies
• Liaises with other PSI departments to collate operational feedback and support patient engagement strategy
• Liaises with Project Management to evaluate the impact of recruitment services on patient enrollment metrics for awarded studies
• Collaborates with Business Development and Feasibility to identify and illustrate the value-add of prioritized recruitment services
• Develops and facilitates training programs to department staff and across key functional areas based on area of expertise

Site Relations Manager

Recruitment

• Operations Develops global enrollment and retention solutions to increase patient screening, randomization, and compliance
• Builds and manages patient engagement service offerings and associated costs for global bids, including vendor and in-house resource allocation
• Designs and implements patient engagement assessments for awarded studies, focused on impact measurement, analysis, and mitigation planning
• Participates in scientific conferences, meetings, symposia, etc. to collect information on patient access and diversity
• Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies
• Communication Liaises with other PSI departments to collate operational feedback and support patient engagement strategy
• Liaises with Project Management to evaluate the impact of recruitment services on patient enrollment metrics for awarded studies
• Collaborates with Business Development and Feasibility to identify and illustrate the value-add of prioritized recruitment services
• Focus on recruitment project delivery, productivity, and quality to ensure strong customer and patient satisfaction for outreach and retention campaigns.
• Communication with sponsors and project teams to implement and monitor impact of PRR programs and tactical plans based on study performance

Manager, Patient Recruitment and Retention Strategy

Full-stack Engineer

• Full-stack development of in-house Data Management department applications (including desktop and simple web applications)
• Perform all development-related activities, including architecting, developing, testing and maintenance
• Prepare of documentation related to development and maintenance of applications
• Use the internal development standards
• Follow the progress of development technologies and advances professional skills as deemed necessary
• Track the development, maintenance and related tasks in the internal tracking system
• Prepare software development plans, including scoping, scheduling, testing and implementation

Full Stack Programmer

• Full-stack development of in-house Data Management department applications (including desktop and simple web applications)
• Perform all development-related activities, including architecting, developing, testing and maintenance
• Prepare documentation related to development and maintenance of applications
• Use the internal development standards
• Follow the progress of development technologies and advances professional skills as deemed necessary
• Track the development, maintenance and related tasks in the internal tracking system
• Prepare software development plans, including scoping, scheduling, testing and implementation

Full-Stack Programmer

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain a good relationship with the site staff involved in the study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
• Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
• Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
• Ensures quality (data integrity and compliance) at site level
• Conduct site audit preparation visits and resolve site audit findings
• Participate in study site audits and client onsite visits, as required
• Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
• Support preparation of draft regulatory and ethics committee submission packages
• Support collection of IP-RED packages at site/country level
• Facilitate review and reconciliation of the study TMF on country and site levels

Clinical Research Associate II

Graphics Designer

• The Lead Digital Designer is responsible for the production of designs & layouts for standalone use or in support of larger print, video and interactive web works and reports directly to the Web Manager.
• Responsibilities Communicate with internal & external clients to gather requirements and guide clients through the design process.
• Organise and translate design and layout scope and requirements into final deliverable items for project plans.
• Create and revise designs and layouts following iterative design processes and project plans.
• Plan processes and recommend creative approaches to designing materials for internal & external use.
• Develop and maintain a library of designs and layouts.
• Manage and organise design projects.
• Oversee art and tool budgets.
• Primarily responsible for the PSI Style Guide.
• Stay abreast with emerging design & layout trends and best practices.