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Position Summary: We have an exciting opportunity to join our team as a Sr Research Coordinator.
In this role, the successful candidate The position will independently manage and oversee the activities of enrolling sites and will be working directly with the core labs for this center grant. The position will act as the lead liaison for enrolling sites and oversee the coordination of the grant trial. In addition, the position will be responsible for: initiating, coordinating and managing research studies conducted at the Medical Center; oversee the financial and protocol development for the assigned studies; assists with managing the recruitment process (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; interface directly with patients/subjects and the Principal Investigator in support of the clinical trials if applicable; and provide guidance to Research support staff. Works autonomously and with limited oversight.
Project Management - Oversees planning/management of study activities and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives. The position will act as the lead liaison for enrolling sites: Oversee tracking of progress at enrolling sites. Develop and/or utilize established processes to assist sites with all aspects of trial participation (ie., site start up requirements, enrollment, randomization, study compliance, data entry, data review and cleaning, continuing IRB review, renewal of regulatory documents and ongoing training). Utilize standard reports available to assess site and study performance. Act as general resource to sites for protocol related questions and GCP related matters. Perform as a key contributor to Project or Program documents (e.g. Protocol, Manual of Operations, SOPs, eCRFs, CRF Completion Guidelines, Working Practices, Training Materials etc.) Identify Project or Program potential problems and/or areas requiring review and/or updating. Serve as Subject Matter Experts for assigned Projects or Processes such as: enrollment process, Core Lab Oversight, Manual of Operations, SOPs, etc. Evaluate issues for broader impact in a timely fashion and ensure resolution. Attend, Lead or Co-lead training meetings/webinars and team meetings as required. Assist with generating and compiling study progress and financial reports and metrics for wide audience Ensure effective Project or Program communications to internal and external stakeholders through meetings, presentations, and other methods. Lead training and update webinars as needed.
Human Subjects Research - As applicable,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. 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.
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. Monitors any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Reminds patient/subjects of visits and compliance in a consistent manner.
Recruitment - Manages 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: 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. [Need relevant reference in requirements for minimum qualifications].
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 research role and maintains 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 peers and works collaboratively with other disciplines within the area of expertise.
Reporting and Analysis Researches, compiles and consolidates data and conducts preliminary analyzes to data collected 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. Formulates, prepares database and generates preliminary measurement reports for review by PI. May complete assessments on study subjects/patients following protocol (with proper training); continues to follow-through with items and patients as part of the research study.
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
Budget - 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.
Decision Making and Problems 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.
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 four years of progressively responsible related experience coordinating clinical/research trials studies. 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.
Preferred Qualifications: Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).Knowledge of basic medical terminology is preferred. Experience working in an Academic Medical Center Preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU 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 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 or 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.
NYU Langone Medical Center, a world-class patient-centered integrated academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of... only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.NYULMC.org.