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Clinical Research Program Director
Full/Part Time: Full Time
Location/Affiliates: The Mount Sinai Hospital
Department: 094 - Critical Care Institute
Requisition Number: 14-1621334
The Clinical Research Program Director of the Institute for Critical Care Medicine (ICCM) exercises direction of a diverse clinical research program that encompasses one of the largest integrated ICU systems in the United States. The program director is responsible for ensuring the successful execution of clinical trials and research studies, helping investigators prepare research grants for extramural funding, IRB processing, interacting with sponsors, managing research budgets, database management, data analysis, and for supervising research staff. The majority of research will focus on enrollment in 24/7 emergency clinical trials focused on stroke, cardiac arrest, sepsis, and respiratory failure.
Duties and Responsibilities
Supervises the operational aspects of multiple clinical trials. Develops and maintains systems which support efficient and effective functioning of clinical research operations. Ensures successful subject enrollment and protocol compliance, including patient screening, the informed consent process, clinical report form (CRF) completion, data management, adverse event reporting, interactions with sponsors, and monitoring visits. Supervises hospital staff training via in-services and e-learning to ensure successful trial execution. The program director is responsible for the integrity and quality of the research, and for ensuring compliance with GCP.
Manages a staff of research assistants that provide 24/7 on-call coverage for emergency clinical trial enrollment at multiple hospital sites. Overnight and on weekends coordinators will screen by phone and must come in to assist in the consent and enrollment process. The program director will be expected to participate in the call rotation. Ensures that all staff are compliant with protocol training and GCP policies
Hires, orients, trains and counsels research staff. Conducts the annual performance appraisal process and manages all related HR activity. Assigns staff to projects as appropriate based on clinical competency and programmatic needs.
Tracks all clinical trial income and expenses. Maintains accurate budgets and works with the Institute Director to ensure a fiscally sound research program. Formulates an annual budget for operation of the program with monthly monitoring of variances. Practices prudent fiscal management.
Assists investigators in the preparation of research grants, including preparation of budgets, contributing to research plan development, and collation and assembly of all components of the final application.
Interacts with IRB to support ethical research procedures, regulatory compliance and good clinical practice. Ensures that the rights of all research subjects are respected. Interacts with FDA and other regulatory agencies as required.
Supervises database managers and generates regular reports, updates, data queries, and statistical analyses. Familiarity with biostatistics and the principles of data management is required.
Maintains and ensures of all research-related equipment and devices, including physiologic data acquisition systems.
Runs or supervises research meetings. Collaborates with all members of the research team and collaborating teams in research program development, planning and delivery.
Serves on appropriate committees as necessary to support the clinical research enterprise.
Education and Experience
HS/GED; specialized training; degree and discipline)
Bachelor's required. Masters or doctoral degree (PhD or MD) in health sciences preferred. Formal training in database management or biostatistics preferred
7 years minimum in a hospital/medical environment, preferably in clinical research
1 year minimum in a supervisory role
Certified Clinical Research Coordinator is preferred but not required.
Microsoft Office suite (Word, Excel, PowerPoint, Outlook) - intermediate proficiency
Excellent written and oral communication)
Superior administrative, time management and organization skills.
Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.