Program Manager-Clinical Research

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Position summary:

The Colorectal Surgery Research Program Manager will coordinate, manage, and execute assigned aspects of human subjects research. In addition to analyzing, writing, and publishing data from large databases to conduct research in the Colorectal Surgery 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 Colorectal Surgery Research Program 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 Colorectal Surgery Research Program Manager will provide hiring, supervision, and training for Sr. Research Coordinators, Research Coordinators, research data associates, student interns, and volunteer study staff as appropriate. This position reports directly to Faculty in the Colorectal with oversight by Departmental Research Leadership.

Job Responsibilities:

Administrative Tasks

Create and maintain study records within all portals of Research Navigator (My Studies, IRB, CRMS, My Agreements, IACUC, etc.) as appropriate for de-identified database analysis and publication
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.
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 NYUGSOM and external regulatory agencies.
Oversee Quality Assurance activities.

Research Duties

Act as primary point of contact for all trials and manage day-to-day communication and activities of the research 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.
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

Data Management

Initiates, interprets, organizes, executes, and coordinates research assignments critical to department's mission including high-level data.
Formulates and conducts research on problems of considerable scope and complexity.
Explores subject area and defines scope and selection of problems for investigation through conceptually related studies or series of projects of lesser scope.
Makes decisions and recommendations that have a major impact on extensive research activities.
Develops new ideas that promote current research.
Exercises a high degree of creativity, foresight, and mature judgment in planning, organizing, and guiding extensive research programs and activities of outstanding novelty and/or importance.
Ensures timely and accurate completion of research projects.
May develop protocol for the collection and quality of research data.
May make significant contributions to scientific papers. Is a resource/ author/ co-author for reports and presentations.
May serve on internal committees to help further goals of research projects and bring new expertise to the research program.
Performs other related duties as assigned.
Researches, compiles and consolidates data and conducts preliminary analyzes to data collected for presentation to sponsoring and regulatory agencies.
Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed.
Formulates, prepares database and generates preliminary measurement reports for review by PI.

Grants Management

Prepares and submit grant applications and other grants related activity such as developing grants applications/proposals and fund-raising activities if applicable.
Collects and organizes required paperwork for submission if applicable.
Follow up and coordinates resolution of all issues progress.
Reports to the sponsors to fund medical research in the division.
May seek grant funding from external sources in support of their independent research projects with consent of the PI and the Department Chair.
May participate in writing grant proposals.

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.
Work with the PI to facilitate study team cohesion and collaboration.
Delegate to junior staff and volunteers as necessary.

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:

Bachelor's 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
Demonstrated ability to troubleshoot and solve complex problems.

Preferred qualifications:

Clinical Research Coordinator certification (CRC) preferred.

Qualified candidates must be able to effectively communicate with all levels of the organization.

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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.
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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 - $126,787.50 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.

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