New York University Langone Medical Center Work Values

Daily Duties at New York University Langone Medical Center:

Supervise 4-member team, clinical and regulatory operations. Manage start-up, maintenance, and closeout of NIH and industry sponsored Phase I-III investigative drug trials for people with mild cognitive impairment or mild-moderate Alzheimer's disease. Develop and amend regulatory documents, IRB submissions, Informed Consent Forms and study site budgets. Attend investigator meetings for new studies as well as tele-trainings for continuing education on protocol amendments, safety updates, administration of assessments and use of databases and interactive voice response systems, including Oracle, PhaseForward, Intralinks, CPAC, InForm, Medidata Rave, UBC-IVRS/IWRS, Cenduit, InfoEd and other CTMS systems. Provide training for support staff on protocols, recruitment, scheduling, psychometric rating, electronic data capture, regulatory submissions and organization, specimen collection and processing. Design and implement standard operating procedures and organizational strategies for increased efficiency and compliance within the office. Enforce Good Clinical Practice (GCP). Manage recruitment and oversee screening visits and follow-up clinical assessments. Monitor Investigator Initiated Proof of Concept Study Conduct Informed Consent Procedures Maintain drug accountability and destruction records Liaise with principal investigators, IRB, CRO, CRA and sponsors for participant safety, recruitment and follow-up, potential trials and regulatory maintenance Interact with monitors during monthly audits to process queries and maintain documents and databases

What they like about New York University Langone Medical Center:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

GCP, Informed Consent, Communication, Management, Leadership, CTMS, EDC, IRB, Budgeting, AE and SAE Reporting, IND Reporting, Monitoring, Drug Accountability, IVRS, InForm, Medidata, IATA, Medical Terminology, FDA, CNS, Alzheimer's, Regulatory, CRO, Coordinator, Start-Up, Clinical Trials

Skills

Technology Solutions, Sales Support, Requirements Analysis & Specification, Trained and certified in ICH-GCP for Research with Human Subjects, Proficient skills using CTMS applications including InForm, Medidata RAVE, Oracle-TAO, FoxPro, ACT!, InfoEd , Developing regulatory documents, budgets, amendments and informed consent forms, Working under pressure and multitasking several projects with strict deadlines, Written Spanish Communication, Oral Spanish Communication, Oral and Written English Communication

These are some of the questions we asked our climbers about their experiences with New York University Langone Medical Center: