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Clinical Research Operations Manager, Vaccine Center at NYU Langone Health in New York, New York

Posted in Other 30+ days ago.

Type: Full Time





Job Description:

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.

Position Summary:

We have an exciting opportunity to join our team as a Clinical Research Ops Manager.

Join the NYU Langone Vaccine Center, a dynamic new multi-disciplinary initiative at NYU Langone Medical Center. The Center Director has conducted virology and human immunology research, and vaccine clinical and translational research, for 31 years. In October, 2018 he became the Director of the new NYU Langone Vaccine Center, Director of the Division of Infectious Diseases and Immunology, the Jeffrey P. Bergstein Professor of Medicine, and a Professor of Microbiology at the NYU School of Medicine. The research portfolio bridges the research laboratory and the research clinic, and includes vaccine clinical trials and translational studies of human immune responses to pathogens and/or vaccines. From 2007-2018, the Center Director was the principal investigator for the National Institute for Allergy and Infectious Diseases (NIAID)-funded Emory Vaccine and Treatment Evaluation Unit (VTEU), one of nine national units. In addition, he served as a multiple principal investigator (MPI) for the NIAID funded Emory CDC HIV/AIDS Clinical Trials Unit (CTU), conducting HIV/AIDS and TB research in Atlanta, Kenya, the Philippines, and Thailand. The research laboratory performs endpoint microbiology and immunology assays in support of these human studies. The NYU Langone Vaccine Center discovers, teaches, and cares; and will perform fundamental research, clinical trials, translational studies, and public policy research.

Job Responsibilities:

* Ascertains that appropriate consents, protocols and forms are properly completed and filed in research chart. Records all required clinical information. Collects data and ascertains that source documents and case report forms are forwarded to appropriate sponsor site in a timely manner. Promptly reports to clinician all untoward reactions observed during the course of treatment, all potentially serious reactions, and any problems encountered. Records immediately all observations in appropriate record. Assure proper GCP training and performance of all team members.

* Participates with the PI and NYU Langone Vaccine Center faculty in preparing research grant and contract proposals.

* Meets with the PI regularly to review approved or proposed projects; participates in planning and evaluating these projects. Participates in staff meetings on a regular basis.

* Screens and directs attention of research faculthy to all patients referred by recruiting and medical/nursing staff as potential candidates for study. Administers appropriate test investigational vaccines/treatments in accordance with protocol; documents observations. Makes patient and chart rounds to observe progress of patient. Demonstrates skill in handling problematic patient care situations when need arises. Participates in monitoring/maintaining a safe environment for staff, visitors and patients through hazard-identification and reporting accident prevention. Contributes to the application of evidence-based research findings to appropriate clinical settings.

* Provides research subject/families and staff with instruction and teaching materials pertinent to protocol, investigational product, and disease management.

* Participates in formal evaluation of own progress, and that of all supervised staff, setting goals toward improvement. Updates practices in accordance with clinical research standards or professional trends. Seeks advanced learning/development experiences independently (e.g., workshops, seminars, conferences, courses). Regularly reviews current research coordinator literature and shares significant information with staff. Participates actively in professional organizations.

* Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in research role and maintains current expertise in area of practice. Maintains annual requirement in continuing research education; employee must demonstrate proof of ongoing research education. Serves as a resource to peers and works collaboratively with other disciplines within the area of expertise.

* Assume responsibility and accountability for assigned responsibilities. Sets priorities in management of other staff. Meets deadlines as required.

* Enters documentation of all medications and/or treatments administered to patients in appropriate medical record. If and when applicable, maintains appropriate records of supplies and investigational drugs in protocol studies as required by government, hospital and FDA regulations. Assists clinician in writing up study conclusion report and research paper. Communicates appropriate information within organization in a timely manner. Reports promptly and accurately all significant clinical events to clinician. Ensures accuracy, usefulness and completeness of all hospital and departmental records and manuals. Contributes to a climate supportive of all departmental and institutional activities.

* Establishes communication with other health professionals to promote and implement research with in assigned unit/department. Collaborates with regulatory coordinator in monitoring all activities, evaluating results and documenting same. Actively participates in appropriate committees with the Department or Institution.

* Contributes to and publishes relevant research findings in collaboration with research staff. Communicates published research findings to staff members. Prepares reports/abstracts for conferences and publication.

* Serves as the Clinical Research Manager at the vaccine research clinic which includes research on infectious diseases and treatments, as well as novel vaccines. Supervision of other research clinic staff. Key manager position reporting to Vaccine Center director.

Minimum Qualifications:

* To qualify you must have a:

* NYS RN License with current registration.

* Graduate of an accredited nursing program.

* Bachelor's Degree in Nursing or higher.

* Prior experience in a clinical research setting required.

* Minimum of 3 years progressively responsible research experience coordinating clinical/research trials and studies.

* RN, NP, and/or PA, or equivalent/greater clinician training, with outstanding clinical research skills and experience.

* Hard worker. Outstanding interpersonal skills.

* Clinical trials management experience, at least 5 years.

* Supervisory experience, at least 5 years. Enjoys teaching, mentoring, and supervising. Outstanding organizational skills..

Required Licenses: Phlebotomy Technician Cert

Preferred Qualifications:

Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective verbal and written communication skills, and strong analytical, organizational and interpersonal skills. Ability to interface effectively with all levels of management and work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Commitment to continuous learning as required by department administration. Ability to make decisions independently. Ability to manage time, multi task and prioritize work. Ability to identify, analyze and solve