Anna Yaffe Email & Phone Number

New York, NY, US

Greater New York City Area

• Implement and oversee clinical research programs for the study department
• Establish and implement guidelines for the collection of clinical data and administration of clinical trials
• Coordinate the ongoing analysis and modification of research protocols
• Manage and coordinate assigned multi-site or large scale clinical trials conducted by a supervising Principal Investigator(s)
• Manage personnel functions
• Assist with the development and execution of operating policies and procedures; ensure compliance with established practices.

Greater New York City Area

• Assist Clinical Research team in the completion of all required tasks to meet departmental and project goals as well as assist CSA team in the planning and completion of regulatory document retrieval for assigned.
• Perform data entry of regulatory documents as well as maintenance of Investigator Information in Clinical Trial Management system.
• Complete and provide CTMS reports to CS Manager and CPM on a regular basis as well as review regulatory documents required for site initiation/drug release in accordance with all local, state and agency rules and.
• Assemble and distribute study materials to Clinical and Project teams, manage assigned sites for feasibility activities, complete investigator questionnaire as well as regulatory document packet.
• Effectively manage CS staff assigned to meet or exceed weekly metrics of CIRB submissions and error rates of completed regulatory packets.
• Assist other members of the team in meeting metrics during the start up period. Serve as resource for CSA team in defining mechanisms to enhance regulatory document quality and assist sites in completion process as.