Research Nurse, Cardiology Clinical Trials

We have an exciting opportunity to join our team as a Research Nurse, Cardiology Clinical Trials.

The Research Nurse will manage a growing portfolio of Cardiology Clinical Trials. The Research Nurse Coordinator plays a central role in planning, implementing and managing clinical research studies. This position will work collaboratively with the Regulatory Specialist and Principal Investigators to ensure adherence to research protocols and compliance with FDA regulations, HIPAA, GCP and institutional policies, and assist with recruitment, enrollment, grant submissions, research data collection and study coordination. Qualified candidates will have experience with industry-sponsored research and proficient communication required for multidisciplinary partnership.

Job Responsibilities:

• Investigational product handling: verification of drug, doses taken, diary review, maintenance, reconciling discrepancies, education/re-education and proper return of unused drug.
• Collaborates with investigators and study team members to recruit, enroll and retain patients on clinical trials while ensuring patient safety and protocol fidelity.
• Oversee the clinical coordination of patient schedules ensuring overall adherence to protocol defined criteria
• Updates and submits necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research.
• Secures accurate signatures and forwards documents and/or forms to appropriate destination in a timely manner.
• Organized tracking and maintenance of study regulatory status and compliance.
• Assists with the informed consent process and ensures that the patient/subject fully understands what is required of them throughout the study.
• Collects patient information for research project(s). This may include abstraction of data from the patient chart (, 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.
• Use tools to facilitate data collection ( calendars, schedules, tracking logs, etc). Audits and updates the database or the case report forms.
• Ensure Serious Adverse Events and other reportable information is reported as per regulatory requirements and protocol, institutional and regulatory timeframes. Completes documentation related to Serious Adverse Events in required timeframe, for internal and external review. Provides follow up information, when clinically available, to Serious Adverse Event or Medical Event/Reportable New Information submissions.
• Conducts study visits, obtains and documents information within the time frame specified
• Collects, compiles and conducts preliminary analyses of data, statistics, and other materials for reports.
• Screens potential patients/subjects for eligibility to the study and schedules the initial visits. This may include researching and 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 include but not limited to: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
• Clinical Competency in performing EKG, vitals, height/weight, 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 training and competencies may be included as required.
• Ongoing continuing education in all areas of research development. It is expected that the employee demonstrates proof of ongoing research education on a yearly basis. Training programs are provided through the SOM.
• Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies. Provides reports to all necessary parties (, the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Conduct primary analysis to collected data. Formulates, prepares databases and generates preliminary measurement reports for review by the PI.
• Assists in the preparation of grant applications and related activities such as developing grants proposals and fund-raising activities. Collects and organizes required paperwork for submission if required. Follows up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division
• Assist in draft budget development. Assists in the preparation of funding proposals.
• Help to identify new potential sponsors/agents for trials and research as assigned.
• Participates in special projects and performs other duties as required

Minimum Qualifications:

To qualify you must have a

• NYS RN License with current registration.
• Graduate of an accredited nursing program. Bachelor's Degree in Nursing, or equivalent combination of education and experience with plans to earn a baccalaureate degree in Nursing.
• Prior RN experience in a clinical setting preferred.
• Experience working with specific indications (department-specific).
• Minimum of 3 years of related experience.
• Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications.
• Effective verbal and written communication skills, and strong analytical, organizational and interpersonal skills. Ability to interface effectively with all levels of management and work and communicate effectively with both internal and external customers.
• Ability to work within a team environment as well as independently.
• Commitment to continuous learning as required by department administration.
• Ability to make decisions independently.
• Ability to manage time, multi task and prioritize work.
• Ability to identify, analyze and solve problems; ability to work well under pressure..
• Required Licenses: Registered Nurse License-NYS

Preferred Qualifications:

• Bachelor's Degree in Nursing is highly preferred.
• Experience working with industry-sponsored research protocols involving Investigational Drugs and/or Devices.
• Spanish speaking a plus

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