Remote Lead Clinical Research Associate

Summary

Join PSI, a leading Contract Research Organization (CRO), as a Study Manager in Mumbai, where you will perform and supervise study startup and site monitoring within global clinical research projects of novel pharmaceutics.

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