Clinical Research Coordinator: Trials & Data

NYU Langone Health; New York (NY); On-site; USD 66,000 - 68,000; Full time

Benefits offered by this job

Comprehensive benefits

Wellness program

Generous time off

Job summary

NYU Langone Health’s Grossman School of Medicine seeks a Research Coordinator to support regulatory duties, data collection, and study coordination for clinical research at the medical center.

The role involves coordinating enrollment, assisting with grant submissions, and liaising with IRB and sponsors, while ensuring adherence to Good Clinical Practices and HIPAA. Interacts with patients, investigators, and the research team under supervision.

Qualifications

• Minimum Bachelor's degree in life sciences or allied health with 0-1 year experience.
• Excellent oral and written communication and interpersonal skills.
• Proficiency with Microsoft Office and internet applications.

Responsibilities

• Study Regulations - Aware of study regulatory status and keeps an up to date copy of regulatory documents. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects and reminds them of visits and compliance.
• 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.
• Continuous Learning: Position requires 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.
• Reporting and Analysis - Gathers and compiles data and assists in consolidating/analyzing data 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. Conduct primary analysis to data collected. Formulates, prepares database and generates preliminary measurement reports for review by the PI.
• Grants - 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.
• Budgets - May develop draft budgets and submit to the Principal Investigator. Assists in the preparation of funding reports to agencies. Helps to identify new potential sponsors/agents for trials and researches as assigned.
• Participates in special projects and performs other duties as required.
• Human Subjects' Research - If applicable, 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. Might prepare and submit monthly enrollment statistics to the Office of Clinical Trials and provide other information in timely manner, as necessary.
• Research Activities - Collects 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. Uses tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc). Audits and updates the database or the case report forms. Conducts study visits, obtains and documents information within the time frame specified. Research, collects, compiles and conducts preliminary analyses of data, statistics, and other materials for reports. Conduct preliminary analysis.
• Recruitment - 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.

Skills

Oral communication

Written communication

Interpersonal skills

Microsoft Office

Education

Bachelor's degree in life sciences or allied health

Tools

Microsoft Office Suite

Job description

NYU Langone Health’s Grossman School of Medicine seeks a Research Coordinator to support regulatory duties, data collection, and study coordination for clinical research at the medical center.

The role involves coordinating enrollment, assisting with grant submissions, and liaising with IRB and sponsors, while ensuring adherence to Good Clinical Practices and HIPAA. Interacts with patients, investigators, and the research team under supervision.