Project Manager at NYU Langone Health in New York, NY
Position
Summary:
We have an exciting opportunity to join our team as a Project Manager. The project manager will manage studies in Heart Failure and Adult Congenital Heart Disease Programs. Responsible for initiating, coordinating and managing research studies conducted at the Medical Center. Oversees the financial and protocol development for the assigned studies. Assists with managing the recruitment process (develops advertising strategy, contacts media outlets and negotiate rates and monitor deadlines for submission of materials), 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. Interfaces directly with patients/subjects and the Principal Investigator in support of the clinical trials if applicable. Provides guidance to Research support staff. Works autonomously and with limited oversight. Job
Responsibilities:
Financial/Protocol Development Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader. Preparation of funding reports to funding agencies. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned. NYU Office of Clinical Trials/IRB If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. 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. Monitors any outward effects or issues regarding patient/subject safety and reports this to the appropriate party. Might oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary. Manage and oversee the trial start up activities. Reporting and Data Analysis Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommends changes/additions to established data fields. Analyses data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility. Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists with the informed consent process and ensures that the patient/subject fully understands what is required of them throughout the study. Monitors any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Reminds patient/subjects of visits and compliance in a consistent manner. Project Management - Oversees planning/management of study activities and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives. Conducts quality checks on study data in accordance with IRB and FDA regulations. Monitor study progress (data, recruitment) and finances against milestones. Helps develop study and departmental SOPs. Grants - Oversees the preparation of grant applications and other grants related activities such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if required for the grant. Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division. Prepare and present reports as requested for sponsors and key stakeholders. Prepares and review documents independently and generates status/progress report. Recruitment - Manages the recruitment process for study/program. Screens potential patients/subjects for eligibility to the study. This may include gathering information from the medical record, physician referral, advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that being:
inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study. Decision Making and Problem Solving Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non solved issues and questions to the supervisor. Oversees approximately 5 research coordinators. Provides guidance, training, leadership to less experienced staff. Responsible for staff evaluations. Assist in the development of strategic planning to ensure proper business development activities with PIs and Director. Participates in special projects and performs other duties as required. Minimum
Qualifications:
To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of five years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. Ability to identify, analyze and solve problems; ability to work well under pressure. Preferred
Qualifications:
Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical terminology is preferred. Project management. Supervisory experience. Qualified candidates must be able to effectively communicate with all levels of the organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
We have an exciting opportunity to join our team as a Project Manager. The project manager will manage studies in Heart Failure and Adult Congenital Heart Disease Programs. Responsible for initiating, coordinating and managing research studies conducted at the Medical Center. Oversees the financial and protocol development for the assigned studies. Assists with managing the recruitment process (develops advertising strategy, contacts media outlets and negotiate rates and monitor deadlines for submission of materials), 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. Interfaces directly with patients/subjects and the Principal Investigator in support of the clinical trials if applicable. Provides guidance to Research support staff. Works autonomously and with limited oversight. Job
Responsibilities:
Financial/Protocol Development Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader. Preparation of funding reports to funding agencies. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned. NYU Office of Clinical Trials/IRB If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. 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. Monitors any outward effects or issues regarding patient/subject safety and reports this to the appropriate party. Might oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary. Manage and oversee the trial start up activities. Reporting and Data Analysis Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommends changes/additions to established data fields. Analyses data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility. Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists with the informed consent process and ensures that the patient/subject fully understands what is required of them throughout the study. Monitors any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Reminds patient/subjects of visits and compliance in a consistent manner. Project Management - Oversees planning/management of study activities and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives. Conducts quality checks on study data in accordance with IRB and FDA regulations. Monitor study progress (data, recruitment) and finances against milestones. Helps develop study and departmental SOPs. Grants - Oversees the preparation of grant applications and other grants related activities such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if required for the grant. Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division. Prepare and present reports as requested for sponsors and key stakeholders. Prepares and review documents independently and generates status/progress report. Recruitment - Manages the recruitment process for study/program. Screens potential patients/subjects for eligibility to the study. This may include gathering information from the medical record, physician referral, advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that being:
inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study. Decision Making and Problem Solving Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non solved issues and questions to the supervisor. Oversees approximately 5 research coordinators. Provides guidance, training, leadership to less experienced staff. Responsible for staff evaluations. Assist in the development of strategic planning to ensure proper business development activities with PIs and Director. Participates in special projects and performs other duties as required. Minimum
Qualifications:
To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of five years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. Ability to identify, analyze and solve problems; ability to work well under pressure. Preferred
Qualifications:
Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical terminology is preferred. Project management. Supervisory experience. Qualified candidates must be able to effectively communicate with all levels of the organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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