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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 will work as part of a team to initiate and manage research studies in the most optimal fashion. Ensure 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. Directly interface with the Principal Investigator, research team and sponsor in support of the clinical trials. Establish liaisons with School of Medicine, and NYU Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Clinical Information Systems, Regulatory staff.
Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study.
Reviewing patient/subject medical history and screening procedures for eligibility to the study.
Registering/randomizing patient/subject according to protocol and internal policies..
Review 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.
Collaborate with various personnel that may be involved in assisting with specific aspects in the study.
Demonstrate knowledge of policies and procedures of the host institution where the study is being conducted and the regulatory requirements such as IRB and other approvals if necessary.
Utilize available resources and established procedures to identify problems for quick resolution.
Conduct monitoring visits
Monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse.
Timely correction of queries stemming from inappropriately reported and or recorded data, initiate prompt data edits for all subsequent questions.
Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records from patient screening through final follow-up.
Record, update, edit and maintain confidential information onto paperwork or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
Respond to requests in a timely manner, give/receive correct information, encourage required dialogue/follow-through.
Report adverse events and serious adverse events to applicable agencies
Secure accurate signatures and forward documents and/or forms to appropriate destination.
Maintains files in an organized and up-to-date manner in order to facilitate their retrieval and maintains copies of all required on-going documentation and forms for the files.
Collect, prepare, ship, and/or store biological materials using universal precautions.
Environmental training is provided for the proper handling and collection of biological substances and the packaging and shipment of samples.
Employee must also complete Standard Precautions and required IRB tutorial.
May complete assessments on study subjects/patients per protocol (with proper training); continue to follow-through with items and patients as part of research study.
May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC).
Protocol Compliance: Ensure that standard steps regarding patient registration, eligibility criteria, follow-up, and required documentation is consistently followed.
Data Collection/Abstraction/Entry: Utilize the appropriate methodologies to collect 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. Use tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc). Enter data into the database or case report forms ensuring data entered is correct and consistent with the source document.
Communication: Clear and concise oral and written communication with research and clinical staff, patients, representatives from sponsors and other medical center staff.
Problem Resolution/Prioritization: Identify, respond to and participate in the resolution of potential and actual problems in conducting studies, using a multi-disciplinary approach.
Teamwork: Cooperate with clinical staff, administration, other SOM and medical center staff members.
Professional: Maintain/enhance professional growth/development through participation in seminars, professional
Development: affiliations and internal training sessions to keep abreast of trends in the field of clinical research.
Reporting: Compile data and assist in consolidating/analyzing data for presentation to sponsoring and regulatory agencies. Provide reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommend changes/additions to established data fields.
Availability: Adhere to departmental policies and procedures with regard to attendance and punctuality
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.
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: 69535784
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.