Clinical Research Operations Manager at NYU Langone Health in New York, NY
Position
Summary:
We have an exciting opportunity to join our team as a Clinical Research Ops Manager. The NYU Langone Vaccine Center is a dynamic, multi-disciplinary program at NYU Langone Health and NYU Grossman School of Medicine. 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 studies focus on clinical trials of Covid-19 vaccine boosters, vaccine responses in pregnant and lactating people, a novel influenza vaccine, a novel yellow fever vaccine, and natural history (laboratory and clinic) studies of viral infections including Covid-19 and influenza. In response to the Covid pandemic emergency, and in addition to the flagship Manhattan research clinic where this position is based, the Vaccine Center opened four satellite research clinics across the NYC area. 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. Works in conjunction with Vaccine Center and Division of ID leadership as part of the leadership group. Minimum
Qualifications:
To qualify you must have a Bachelor's Degree or higher in a related field. Prior experience in a clinical research setting required. Minimum of 5-10 years progressively responsible research experience coordinating clinical/research trials and studies. Hard worker and strong leader. Outstanding interpersonal skills. Clinical trials management experience, at least 5 years, minimum 10 year preferred. Supervisory experience, at least 5-10 years. Able to independently manage a large clinic staff. Enjoys teaching, mentoring, and supervising. Outstanding organizational skills. Inspiring communicator and leader. 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
We have an exciting opportunity to join our team as a Clinical Research Ops Manager. The NYU Langone Vaccine Center is a dynamic, multi-disciplinary program at NYU Langone Health and NYU Grossman School of Medicine. 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 studies focus on clinical trials of Covid-19 vaccine boosters, vaccine responses in pregnant and lactating people, a novel influenza vaccine, a novel yellow fever vaccine, and natural history (laboratory and clinic) studies of viral infections including Covid-19 and influenza. In response to the Covid pandemic emergency, and in addition to the flagship Manhattan research clinic where this position is based, the Vaccine Center opened four satellite research clinics across the NYC area. 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. Works in conjunction with Vaccine Center and Division of ID leadership as part of the leadership group. Minimum
Qualifications:
To qualify you must have a Bachelor's Degree or higher in a related field. Prior experience in a clinical research setting required. Minimum of 5-10 years progressively responsible research experience coordinating clinical/research trials and studies. Hard worker and strong leader. Outstanding interpersonal skills. Clinical trials management experience, at least 5 years, minimum 10 year preferred. Supervisory experience, at least 5-10 years. Able to independently manage a large clinic staff. Enjoys teaching, mentoring, and supervising. Outstanding organizational skills. Inspiring communicator and leader. 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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