Clinical Research Operations Manager

New York, NY

Employer:	NYU Langone Health
Category:	Health Care
Job Type:	Full Time
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. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram. Position Summary: We have an exciting opportunity to join our team as a Clinical Research Operations Manager. Join the NYU Langone Vaccine Center a dynamic multi disciplinary program at NYU Langone Health and NYU Grossman School of Medicine as the clinical operations manager for the flagship Manhattan research clinic of the Vaccine Center The Center Director has conducted vaccine clinical and translational research for 34 years In 2018 the new NYU Langone Vaccine Center was established https://med nyu edu/centers programs/vaccine/ The expanding research portfolio bridges the research clinic and the research laboratory and includes vaccine clinical trials and translational studies of human immune responses to pathogens and/or vaccines In 2020 a major seven year NIH/NIAID grant was awarded to the Vaccine Center: designation as one of only ten national Vaccine and Treatment Evaluation Units VTEUs https://www niaid nih gov/research/vaccine treatment evaluation units intro The NYU Langone Vaccine Center discovers teaches cares and leads; and performs fundamental research clinical trials translational studies and public policy research The research laboratory performs microbiology and immunology assays in support of these human studies Current research includes clinical trials to study novel vaccines to prevent infectious diseases of public health importance such as COVID 19 influenza C Diff RSV novel drug HIV and observational studies to understand the immune response to vaccines and infections such as mpox The NYU Langone Vaccine Center also aims to increase access to care and combat vaccine hesitancy in New York City and globally Job Responsibilities: Participates with the PI, Program Director and Center faculty in preparing research grant and contract proposals, and in designing and/or implementing new research projects in the clinic as the leader of a large staff of nurses and coordinators. Manages the clinic staff. Meets with the PI, Program Director and Center faculty regularly to review studies that are enrolling participants, are in active follow up, or are starting imminently. Serves as the staff leader and participates in planning and evaluating these projects. Leads staff meetings on a weekly basis. Participates in weekly or recurring protocol team meetings with national/international sponsors (NIH, industry, academia) and collaborators and/or vaccine center teams. Oversees the clinic staff to ensure appropriate enrollments, consents, procedures, safety evaluations, documentation, and specimens are completed. Assure proper GCP training and performance of all team members. Demonstrates skill in handling challenging clinical research situations when need arises. Participates in monitoring/maintaining a safe environment for staff, visitors and patients through hazard-identification and reporting accident prevention. Provides research 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. Helps lead staff educators, and participates in community education, engagement and recruitment activities. Sets priorities in management of other staff. Able to mentor the staff and help them be successful. Other duties as assigned by Center director and program director. Meets deadlines as required. 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 clinic 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 within assigned unit/department. Collaborates with regulatory coordinator in monitoring all activities, evaluating results and documenting same. Actively participates in appropriate committees within 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. Supervision of other research clinic staff. Key manager position reporting to Program Director-VTEU. 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 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 problems; ability to work well under pressure Ability to supervise others and help them be successful in their work tasks Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $97,589.96 - $162,649.75 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. To view the Pay Transparency Notice, please click here

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Clinical Research Operations Manager

New York, NY

Description