Clinical Research Program Manager - Heart Valve Center
NYU Langone Medical Center
Location: New York, New York
Type: Full Time
Required Education: High School
Admin / Clerical
Internal Number: 98970399
NYU Grossman School of Medicine 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 NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed,Facebook, Twitter and Instagram.
Position Summary: We have an exciting opportunity to join our team as a Program Manager - Heart Valve Program.
The position will supervise the Heart Valve Program Clinical Research team consisting of six or more research coordinators and program/project assistants. The position will also be responsible for providing moderate to advanced range of coordination of Research studies conducted at Medical Center (initiating, coordinating and managing research studies, etc). Oversees the financial and protocol development for all studies. Oversee the management and assist with the recruitment process as needed: 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. Works autonomously and with limited oversight.
Participates in special projects and performs other duties as required.
Demonstrates knowledge of the organization's Core Values and incorporates them into the performance of duties.
Supervisory - Recruit, hire, train, complete employee performance reviews, and supervise research coordinators, project assistants, and volunteers for the program and ensures all office policies and procedures are being implemented.
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; Central IRBs If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials, and Central IRBs (when applicable) 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.
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.
Data Management Oversee and may be responsible for collecting and auditing patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc); abstraction of data for publications, or data collection from outside physicians offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports. Conducts study visits, obtains and documents information within the time frame specified.
Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. As needed, 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, Physician Assistant and Research Nurse. Reminds patient/subjects of visits and compliance in a consistent manner.
Project Management - Oversees planning/management of study activities for the whole team and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives.
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.
Recruitment Oversees and may manage 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.
Clinical Competency - Position may require competency in performing EKG, phlebotomy technique, centrifuge, handling, storing and shipping of specimens. Clinical training and didactic competency tests may be required to perform basic procedures as part of position expectations. In house training and certification will be provided. Other trainings and competencies may be included as required.
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 Principal Investigator or manager as needed.
Continuous Learning Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in role and maintain current expertise in area of practice. Maintains annual requirement of 10 CEUs in continuing research education; employee must demonstrate proof of ongoing research education. Serves as a resource to the research team and works collaboratively with other disciplines within the area of expertise.
Minimum Qualifications: Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of 3 years of progressively responsible related experience coordinating clinical/research trials studies and at least 1 year of supervisory experience. 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. Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).
Preferred Qualifications: Master's Degree preferred. Knowledge of medical terminology is preferred.
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. To view the Pay Transparency Notice, please click here.