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.• Responsible for providing moderate to advanced range of coordination of Research studies conducted at the Medical Center. • Assists with the recruitment, enrollment, grant submissions, research data collection and study coordination activities. • Performs intra-operative monitoring and serves as liaison with internal and external funding agencies. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and sponsor. • Interfaces directly with patients/subjects and Principal Investigator in support of the clinical trials if applicable. • Establishes liaisons with relevant parties at the Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems and regulatory Services. • Might assist in the initiation and management of research studies. Works under general direction.

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 projects.• 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 regulations. • 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 well as contact clinical sites for specific requests (e.g., incomplete regulatory documents, missing documentation, meeting arrangements, etc.), and complete phone log for each assigned site. • Provide feedback and assistance to CSAs to assist in process improvement and conduct collection, review and tracking of regulatory documents as primary or secondary reviewer depending on study needs. • Conduct periodical quality control audits of clinical study documentation. Coordinate meetings and activities. Assist in the training of new staff and provide ongoing training for all CSA staff. • Assist CSA team by review of reports prior to submission to Clinical PM. Serve as resource for CSA team in defining mechanisms to enhance regulatory document quality and assist sites in completion process.