Position Summary:

We have an exciting opportunity to join our team as a Program Manager.

The position will supervise the Heart Failure Clinical Research Program consisting of research coordinators and program/project assistants. Responsible for initiating, overseeing the conduct, progression, compliance, management of research studies within the Division of Cardiology, Prevention Center, providing moderate to advanced coordinating. Monitors study timelines and ensure timely implementation of work plans. Submits IRB applications and monitors approval and addendum processes. Works with the Assistant Director of Cardiology Clinical Research to develop study budgets and to ensure billing compliance. Assists in the day-to-day supervision and motivates the research team to sustain highly productive and professional activities. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator (PI), research team and the various sponsors. If applicable, may interface directly with patients/subjects and the Principal Investigator(s) in support of the clinical trials. Provides guidance to research support staff. Works autonomously and with limited oversight. Works with Division leadership to regularly report metrics on study status. Performs intra-operative monitoring and serves as liaison with internal and external funding agencies, sponsors, and CRAs.

Job Responsibilities:

• Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
• Assists the Assistant Director in recruiting, hiring, training, and completion of employee performance reviews. PM will 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 budgets, monitors budget throughout trial and recommends staffing levels based on reviewed protocol under the guidance of the Assistant Director. 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. Consistently makes sure study team is entering visits into the CRMS system as well as invoicing for other identifiable items in a timely manner.
• Regulatory- Oversees the submission of necessary documents required by the NYU Institutional Board (IRB), Bellevue Hospital, 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. Oversees the monthly enrollment statistics submission to the Assistant Director, PIs, 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 (if applicable). 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. Makes sure study visits occur and 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. Performs QA/QI audits for studies and works with study team to correct any noted inconsistencies. Works with Assistant Director to develop and improve on any SOPs.
• 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 unsolved 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. Serves as a resource to the research team and works collaboratively with other disciplines within the area of expertise.
• Reconciles revenue and expenses across all NYU systems (Epic, CRMS, Research Navigator, and PeopleSoft Finance in collaboration with Financial Analyst).
• Organizes and attends research meetings.
• Ensures timely and accurate completion of research projects.
• Participates in special projects and performs other duties as required.

Minimum Qualifications:

To qualify you must have a 1. Bachelor degree or equivalent in business administration, health care administration or related discipline.
2. Minimum of 3 years of progressively responsible related experience coordinating clinical/research trials studies and at least 1 year of supervisory experience.
3. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications.
4. Effective oral, written, communication, interpersonal skills.
5. 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.
6. Ability to work and make decisions independently.
7. Time management skills and ability to multi-task.
8. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials.
9. Ability to identify, analyze and solve problems; ability to work well under pressure.
10. Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).
11. Flexible work hours, if required (outside 9am-5pm hours).

Preferred Qualifications:

Master's Degree preferred. Knowledge of medical terminology is preferred. Cardiology experience is preferred.

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

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 $84,577.92 - $91,000.00 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.

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