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Position Summary: We have an exciting opportunity to join our team as a Research Coordinator.
In this role, the successful candidate is responsible for providing moderate to advanced range of coordination of Research studies conducted at the Medical Center. Assists with the recruitment, enrollment, grant submissions, research data collection and study coordination activities. 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 sponsor and attends all appropriate trainings. Interfaces directly with patients/subjects and Principal Investigator in support of the trials as applicable. Establishes liaisons with relevant parties at the Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems and regulatory Services. Might assist in the initiation and management of research studies. Works under general direction.
Human Subjects Research As applicable, oversee the submission of 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 (e.g., ensures the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrollment statistics 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 ensure that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects reminding them of visits and compliance. May monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Act as point of contact for assigned trials. Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visits, Acts as internal auditor during quarterly internal audits for other studies.
Data Management 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. Conducts study visits, obtains and documents information within the time frame specified. Review issues that deviate from standard policy or trial with PI/supervisor and report appropriately.
Recruitment - 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 then 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.
Enriched learning experiences if applicable: Attend study specific investigator/coordinator meeting, assist with preparation and submission of posters, assist with preparation and submission of publications.
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 Prepares and submit 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 applicable. Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division.
Budget - Develops a preliminary draft budget and submit to the Director/Principal Investigator. Reviews sponsor-proposed budget for adequate coverage and recommend changes as appropriate. Assists in the preparation of funding reports to funding agencies and helps identify new potential sponsors/agents for trials and researches. Monitor budget throughout trial including study milestones and patient accruals.
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 and refers non solved issues and questions with recommendation to supervisor.
Participates in special projects and performs other duties as required.
Minimum Qualifications: To qualify you must have a Bachelor's degree in life sciences, allied health or equivalent in a related discipline and 0-1 years experience or an equivalent combination of education and experience. Effective oral, written, communication, interpersonal skills. Must be able to work under the direction of supervision. Ability to operate research related equipment. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Ability to identify, analyze and solve problems. Time management skills and 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 and 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. If you wish to view NYU School of Medicine's EEO policies, please click here. Please click here to view the Federal 'EEO is the law' poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.
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Internal Number: 67437459
About NYU Langone Medical Center
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.