Remote Lead Clinical Research Associate

Summary

Join PSI, a leading Contract Research Organization (CRO), as a Study Manager to perform and supervise study startup and site monitoring within global clinical research projects of novel pharmaceutics. This role involves monitoring project timelines, implementing corrective measures, communicating with sponsors and sites, and managing CRAs.

Requirements

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• Participation in clinical projects as a Lead/Senior Monitor
• Independent on-site monitoring experience in India
• Full working proficiency in English
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, leadership, and problem-solving skills
• Ability to travel

Responsibilities

• Monitor project timelines and patient enrollment, implements respective corrective and preventive measures
• Act as the main line of communication between the Sponsor, Project Manager and sites for systemic protocol-related updates
• Be involved in clinical site monitoring and management activities
• Coordinate investigator/ site feasibility and identification process
• Coordinates study startup
• Review IP-RED/ site regulatory packages
• Review monitoring visit reports for all visit types and ensures reporting compliance of CRAs
• Manage CRAs in the query resolution process, including Central Monitoring observations
• Coordinate safety information flow and protocol/process deviation reporting
• Perform clinical supplies management with vendors
• Ensure study-specific and corporate tracking systems are updated in a timely manner
• Conduct supervised monitoring visits in the projects
• Provide project-specific training to project teams and prepare training materials for the project teams
• Manage the project team in site contracting and payments
• Lead project team calls on a country level
• Provide status updates and reports to Regional Lead/ Project Manager
• Deliver trainings and presentations at Investigator Meetings, conduct project specific trainings of Investigators
• Supervise Site Management Associates in maintaining tracking systems, document and laboratory supplies flow
• Conduct site audit preparation visits, may participate in site audits, and coordinate resolution of site audit findings