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Position Summary:

The Hepatobiliary & Pancreatic Surgery Research Project Manager will coordinate, manage, and execute assigned aspects of human subjects research (i.e. clinical trials, pilots, global consortia, and collaborative intradepartmental studies) and basic science research in the Hepatobiliary & Pancreatic Division of the Department of Surgery. This includes projects with various sources of funding (i.e. industry sponsored, federal, foundations). The role will work closely with the Principal Investigator(s), research designees, and administrative leaders to coordinator and oversee research projects through from start to finish while ensuring compliance and scientific integrity. The Hepatobiliary & Pancreatic Surgery Research Project Manager is responsible for ensuring that studies are carried out in accordance with institutional, state, and federal regulations and standard operating procedures, and is accountable for the day-to-day operations, finances in collaboration with the senior financial analysts and department/divisional leadership, and execution of study activities to ensure the studies are conducted per regulatory compliance. The Hepatobiliary & Pancreatic Surgery Research Project Manager will provide supervision, and training for Sr. Research Coordinators, Research Coordinators, research data associates, student interns, and volunteer study staff as appropriate.

Administrative Tasks

• Support PIs in preparation and submission of required reports (annual, progress, financial, safety etc.) to grants POD, SPA, etc. for 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, IACUC, etc.) and Regulatory Binders.
• Assist in protocol development & grant writing as needed.
• Support PI in grant submissions including obtaining appropriate documentation, letters, and editing 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 and grants team as necessary (Consulting, Data Sharing, Biospecimen transfer, etc.).

Research Duties

• Act as primary point of contact for all trials and manage day-to-day communication and activities of the clinical or research trial team.
• Meet regularly with the PI to review and monitor the overall conduct of all research projects.
• 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.
• Handle, collect, prepare, transport and ship biological specimens as required by study protocols.
• Schedule and coordinate study visits as needed.
• 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.
• Conduct study visits with Research Staff and PI, collect data as required.
• Lead the ongoing recruitment efforts at Tisch Hospital, Bellevue Hospital Center and outside sources to ensure subject accrual goals.
• Establish and cultivate relationships with NYU clinical staff including physicians,  advanced practice providers (APPs) , social workers, etc. in efforts to recruit patients and maintain positive affiliation.
• Create and place advertisements in various media platforms as approved by the IRB so as to expand recruitment efforts to the general population who may be interested in potentially participating in respective research projects if needed.
• Initiate and schedule meetings/presentations/outreach activities between the study staff and medical center staff and treatment demographic population.
• Review and audit data entered by study personnel
• 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, if required.

Lab Management

• Manages the day-to-day operations of the HPB Division Laboratory under Dr. Wolfgang and Dr. Javed.
• Overseeing conduct, operations, compliance, and efficiency of all laboratory experiments, and provide experimental support, as part of the laboratory’s scientific mission
• As needed, will assist with any animal colony and supply management, if applicable
• Develops, maintains, processes, and implements laboratory operating policies, procedures, and documentation.
• Provides assistance to other lab members, collaborators, post-doc fellows, etc. with experimental design and data analysis.
• Maintain Institutional Biosafety Committee, and International Animal Care and Use Committee (IACUC) and other facilities approvals.
• Responsible for ordering key supplies and maintaining inventories, specimen processing, shipping and receiving shipments, chemical inventory, waste disposal, and inspections, as needed.

Personnel Management

• Mentor junior staff, student interns, and volunteer study staff throughout the course of all studies.
• Provide day-to-day oversight, training, and support to postdoctoral fellows, graduate students, other trainees, and research staff.
• Review and confirm MyTime time management system for study team members with the division administrator and administrative coordinator, if required
• Appropriately trains staff to ensure appropriate knowledge, skill set and coverage of all areas within the laboratory.
• Maintains comprehensive training records of lab members.
• Work with the PI to facilitate study team cohesion and collaboration.
• Delegate to junior staff and volunteers as necessary.
• Description Expense Management and Finance Control

• Ability to develop budgets for research projects
• Ensure accuracy and timeliness of study consultant and vendor payments as well as study subject reimbursement and compensation payments.
• Maintain and manage grant/study expenses in collaboration with Institutional resources assigned to the Department of Surgery , and ensure they are within budget.
• Oversee study materials and supplies & monitoring quantities.
• Initiates ordering or new supplies with reference to study budgets when necessary.
• Work directly with the PI, Division Administrator, Department Research Leaders and Administrators, Senior Research Financial Analysts, and sponsors to ensure open and accurate communication regarding the study funds.

Minimum Qualifications:

Bachelors Degree required. Masters Degree in science or related field preferred 
 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

Preferred Qualifications:

Clinical Research Coordinator certification (CRC) preferred.
Flexible schedule preferred as occasional weekend work may be required pending study needs

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 $81,325.15 - $125,000.00 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 click here