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Position Summary: We have an exciting opening for a Program Manager position within the Ronald O. Perelman Department of Emergency Medicines Research Division.
In this role, the successful candidate will primarily work on an innovative, Patient Centered Outcomes Research Institute-funded project comparing the effectiveness of nurse-delivered telephonic versus specialty outpatient palliative care in older adults with serious illness discharged from the Emergency Department.
The Program Manager will be responsible for coordinating research activities across all participating clinical sites (nine total) and supervising study staff. In addition, the program manager will be responsible for the development, promotion, direction and coordination of the trial, including research design, budget, staffing, logistics and other supportive functions for the assigned trial sites. He or she will facilitate and have overall responsibility for the administration of assigned trial activities (staff on-boarding process, following up with study sites, assisting in the submission of IRB/EC/national regulatory documents, developing budgets, scheduling meetings, planning, organizing and coordinating events, training others etc). He or she will work autonomously with limited oversight. Oversees the financial and protocol development for the assigned studies. Assists with managing the recruitment process, enrollment, grant submissions, and study coordination. Performs intra-operative monitoring and serves as liaison with internal and external funding agencies. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor.
1. Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
2. The Program Manager will be responsible for the development, promotion, direction and coordination of the trial, including research design, budget, staffing, logistics and other supportive functions for the assigned trial sites. Facilitates and has overall responsibility for the administration of assigned trial activities (staff on boarding process, following up with study sites, assisting in the submission of IRB/EC/national regulatory documents, developing budgets, scheduling meetings, planning, organizing and coordinating events, training others etc). Works autonomously with limited oversight.
3. Manage and oversee the trial start up activities including development/revision of the final protocol, template informed consent for site use, study manual of operations, CRF guidelines and study training materials
4. Oversee and manage the logistics around a new site start-up, including activities such as finalizing customized informed consents, finalizing and submitting IRB submissions and respond to queries, reviewing site regulatory documents, negotiating budget terms etc.
5. Oversee the operations of the clinical trial sites, and serve as the primary liaison with principal investigator
6. Prepares reports on status of sites. Follows up and resolves issues as it relates to processing of site contracts
7. Prepares and issues reports within established procedures. Analyses findings of central review and monitor site source documents, and presents recommendations. Prepares and review documents independently and generates status/progress reports, collaborating with data management and sites to resolve site issues.
8. Oversees and coordinates all site study close-out activities
9. Acts as the primary liaison and resource to assigned sites for protocol related questions and GCP related matters
10. Develops study SOPs and documenting best practices
11. Develops, prepares and revises training materials, develops curriculum, database management and ensures satisfaction through various measurement tools.
12. Attending and co-lead training meetings/webinars, team meetings as required
13. Responsible for the management, generation, analysis and compiling of study progress reports, financial reports and metrics for a wide audience, including NHLBI, the Steering Committee, DSMB, etc.
14. Recruit, hire, train and supervise Clinical Research Associates, volunteer Research Associates, and ensures all policies and procedures are being adhered to and implemented. Responsible for completing annual performance reviews through ePerformance.
15. Frequent out of state travel to visit participating sites and facilitate trainings
16. Participates in special projects and performs other duties as required.
Minimum Qualifications: To qualify you must have a
1. Bachelors degree or equivalent in health care administration or related discipline. 2. Minimum of four years progressively responsible related experience coordinating clinical/research trials studies. 3. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. 4. Effective verbal and written communication skills, and strong analytical, organizational and interpersonal skills. 5. 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. 6. Commitment to continuous learning as required by department administration. 7. Ability to make decisions independently. 8. Ability to manage time, multi task and prioritize work. 9. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. 10. Ability to identify, analyze and solve problems; ability to work well under pressure.
Preferred Qualifications: 1. Masters Degree in health care administration or related discipline is preferred 2. Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). 3. Knowledge of basic medical terminology is preferred. Experience working in an Academic Medical Center preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU 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 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 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. To view the Pay Transparency Notice, please click here.
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