NYU School of Medicine Research Project Manager - Center for Alcohol Use Disorder and PTSD Research in New York, New York
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 , 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, and interact with us on,,,Facebook,TwitterandInstagram. Position Summary: We have an exciting opportunity to join our team as a Research Project Manager. In this role, the successful candidate The Research Project Manager will independently manage and execute all aspects on a number of private and federally funded clinical trials and studies in the AUD and PTSD ResearchProgram at the Department of Psychiatry, namely overseeing and ensuring expert execution ofthe Department of Defense funded studies such as the Advanced Precision Psychiatry for Military Service Related Clinical PTSD Subtypes, Gabapentin R01, and other clinical trialswithin the portfolio. She/He will work closely with the Sr. Research Project Manager, PrincipalInvestigators, Clinical and Data core teams, and Systems Biology Consortium leaders to seeresearch projects through from start to finish while ensuring compliance and scientific integrity. The Research Project Manager is responsible for ensuring that studies are carried out inaccordance with institutional, state, and federal regulations and standard operating procedures,and is accountable for the day-to-day operations, finances, and execution of clinical trials to ensure the trial activities are conducted per regulatory compliance. The Research ProjectManager will provide supervision, and training for research data associates, researchcoordinators, student interns, and volunteer study staff. Job Responsibilities: Database and Biospecimen Transfer Management Oversight Oversee creation and SOP management of several large, big data databases, REDCaps, LabVantage, Big Purple, biospecimen/biorepository tracking systems and entry for all studies, ensuring accurate and timely input, as well as organized and clean data/specimen quality Oversee shipping and delivery (logistics, coordination, contracts, etc.) for the secure and safe shipping and transfer of large biospecimens, as well as their safe storage in accordance with developed guidelines and established SOPs. Lead and coordinate the complex transfer of database files and data points between multiple institutions, technicians, and biostatisticians upon request and for interim analysis under the guidance regulatory compliance and contracted language. Ensure contractual and protocol compliance: standard steps regarding safety and security as well as integrity of data/biospecimens are adhered and required documentation consistently followed in the time frame specified. Review and audit data entered by study personnel Administration, Analysis, Reporting, and Compliance Prepare and submit of reports (annual, progress, financial, safety etc.) to regulatory agencies, federal & state oversight organizations, data & safety monitoring boards and study sponsors. Create and maintain study records within all portals of Research Navigator (My Studies, IRB, CRMS, My Agreements, etc.) and Regulatory Binders. Prepare submissions as necessary. Maintain FDA INDs held by the PI/Investigators. Prepare and submit of applications for PI/Investigators DEA and BNE Licensure & Registration. Assist in protocol development & grant writing as needed. Establish and follow Standard Operating Procedures to ensure adherence to trial protocols and administrative requirements. Ensure study team personnel adherence to Good Clinical Practice and compliance with NYUSoM and external regulatory agencies. Oversee Quality Assurance activities. Facilitate agreements in collaboration with SPA as necessary (Consulting, Data Sharing, Biospecimen transfer, etc.). Clinical Research Duties Act as primary point of contact for all trials and manage day-to-day communication and activities of the clinical trial team. Meet regularly with the PI to review and monitor the overall conduct of the study. Utilize available resources and established procedures in order to rectify problems and communicate all changes. Prepare internal and external memos, source document and case report form templates, reports, and correspondence required to properly manage and document activities on the studies. Coordinate study-drug shipment, accountability and compounding. Handle, collect, prepare, transport and ship biological specimens as required by study protocols. Schedule and coordinate study visits as needed Conduct study visits with Research Staff and PI, collect data as required - particularly needed clinical measures, such as SCIDs, CAPS, etc. Personnel Management Mentor junior staff, student interns, and volunteer study staff throughout the course of all studies. Oversee MyTime time management system for study team members. Coordinate promotions and new hire requisitions as needed under the supervision and guidance of the Sr. Project Manager Onboard and supervise junior staff as needed. Work to PI to facilitate study team cohesion and collaboration. Delegate to junior staff and volunteers as necessary. Recruitment & Retention Establish and cultivate relationships with NYU clinical staff including physicians, NPs, social workers, etc. in efforts to recruit patients and maintain positive affiliation. Lead the ongoing recruitment efforts at Tisch Hospital, Bellevue Hospital Center and outside sources to ensure subject accrual goals. Create and place advertisements in various media platforms so as to expand recruitment efforts to the general population who may be interested in potentially participating in respective research projects. Initiate and schedule meetings/presentations/outreach activities between the study staff and medical center staff and treatment demographic population. Obtain informed consent, assess for eligibility and coordinate subsequent study visits with enrolled participants. Maintain study-specific logs with regards to NYUSOM IRB, NYS and Federal regulations. Expense Management and Finance Control Ensure accuracy and timeliness of study consultant and vendor payments as well as study subject reimbursement and compensation payments. Oversee study materials and supplies & monitoring quantities. Initiates ordering or new supplies with reference to study budgets when necessary. Work directly with the Sr. Research Project Manager, PI, Department administrator, program manager, and sponsors to ensure open and accurate communication regarding the study funds. Ability to read and comprehend sponsors' budget Minimum Qualifications: Bachelor's Degree required. 5 years of clinical research project management experience Computer literacy: proficiency using Microsoft Office applications such as Word, Excel,Power Point and Outlook. Effective oral, written communication, and interpersonal skills Effective time management skills and ability to work well under pressure Exceptional organization skills and attention to detail Ability to work and make decisions independently 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 . Please 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 City Law on Salary Transparency in Job Advertisements. The salary range for the role is $76,721.84 - $93,600.00 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 NYU Langone Medical Center 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.