NYU SOM Position Description
|Title: Senior Research Coordinator||Job Code:|
|Reports to: Manager and above||Salary Grade:|
|FLSA Status: Exempt||Standard Workweek: 35|
The Translational Neuroeconomics laboratory within the Neuroscience Institute of the NYU Grossman School of Medicine is recruiting an experienced full-time senior research coordinator to fill an immediate opening. The successful candidate will be responsible for initiating, coordinating and managing a new National Institute of Health (NIH) funded clinical trial that will test the impact of a smartphone intervention on opiate reuse and relapse, during pharmacologic treatment for opioid use disorder. The employee will oversee financial and protocol development for the assigned studies. Assist with managing the recruitment process, enrollment and study coordination. Ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient, Principal Investigator, research team and the sponsor. Interface directly with patients, the Principal Investigator, research assistants, and postdoctoral fellows at the 4 study sites. Work autonomously and with limited oversight.
- Demonstrates knowledge of the organization’s Core Values and incorporates them into the performance of duties.
- NYU Office of Clinical Trials/IRB – 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. Participates in monitoring issues regarding patient/subject safety. Oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
- 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.
- Project Management – Oversees planning/management of study activities across the 4 study sites and interfaces with the postdoctoral fellows operating at each site. Co-supervises Reasearch assistants at the sites.
- Recruitment – Oversees the recruitment process for 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.
- 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.
- 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.
- 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.
- Provides guidance, training, leadership to less experienced staff. May have input into staff evaluations.
- Participates in special projects and performs other duties as required.
- Bachelor degree or equivalent in life sciences, public health, clinical psychology, social work, business administration, or health care administration.
- Minimum of four years of progressively responsible related experience coordinating clinical/research trials studies or PMI/CCRC/CCRP certification and 2-years experience, or graduate degree and one-year experience.
- Solid understanding of the life cycle of a clinical trial, strong judgment, and excellent project management skills
- Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Project management software.
- 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.
- Masters’ Degree in Public Health.
- Previous experience in clinical research (Phase I-IV or HEOR).
- Experience working with individuals at safety-net hospitals.
- Experience working with Substance Use Disorders.
- Proficiency in Spanish.