Clinical Research Assistant

Job ID: 1160080_RR00118777 NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. Position Summary We have an exciting opportunity to join our team as a Clinical Research Assistant. The role involves providing direct data and/or clinical research to support clinical trials, studies and general research under direct supervision. The position works with School of Medicine and Medical Center staff and departments, including Directors, Managers, Clinical Information Systems, Research Nursing and Regulatory Services, and may also interface with patients and their families. Job Responsibilities Respond to requests in a timely manner, give and receive correct information, encourage required dialogue and follow-through. Utilize the necessary tools to ensure protocol compliance to conduct direct data research. Review data with supervisor and provide reports to the data and safety monitoring committee. Track study milestones and patient accruals to help evaluate the progress of studies. Utilize available resources and established procedures to rectify problems, communicate all changes. Recognize and identify problems, appropriately elevate issues to supervisor as needed. Demonstrate knowledge of and follow proper clinical study processes within current policies and procedures. Work with research nurses as part of a team to coordinate clinical trials. Work with the principal investigators and research nurses on monitoring the overall conduct of the study. Monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Conduct study visits, obtain and document information within the time frame specified. Utilize available resources and established procedures to identify problems for quick resolution. 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. Interact with patient/subject and families in a courteous and professional manner. Collaborate with various personnel that may be involved in assisting with specific aspects in the study. Review all the elements of the screening process with the Principal Investigator. Assist with the informed consent process. Recruit potential patients/subjects for eligibility to the study. Have thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study. Liaise with monitors during site visits, providing them with assistance specific to the monitoring visit. Initiate and continue regular contact with patients; encourage visit reminders and compliance to research; ensure contact with patients and their families is courteous, effective, professional and cooperative. Interface with varied persons, such as School of Medicine and or Medical Center staff (e.g. physicians, nurses, CTO). Coordinate, facilitate and communicate with Staff and Non-Staff to produce required results. May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC). Draw patients/subjects blood, perform EKG, and/or take vital signs (if proper training has occurred). Complete assessments on study subjects/patients per protocol (with proper training); continue to follow-through with items and patients as part of research study. Attend appropriate trainings in the proper handling and collection of biological substances and the packaging and shipment of samples as well as required IRB and HIPAA tutorial. Collect, prepare, ship, and/or store biological materials using universal precautions. Follow-ups to ensure that requested materials are delivered according to all appropriate procedures and policies. Utilize established methodologies to collect patient information for the research project(s). May prepare presentation for lectures and symposium, utilizing PowerPoint for slides. May request articles from medical journals. May perform library searches and retrieve reference materials from various sources using Medline and PubMed. Ensure that information in computer database is accurate, entered and maintained on a timely basis. Prepare requested data and numbers thoroughly and accurately for statistical analyses and required reporting. Review data to be entered, edit obvious errors and obtain missing information. Maintain copies of all required on-going documentation and forms for the files. Complete paperwork and forms in a neat, accurate, timely manner and ensure subsequent data collection as required. Process incoming and outgoing documents by transcribing data, figures, statistics, codes and other information. Suggest changes and additions to established data fields as needed, to supervisor. Input clinical and non-clinical data into the database and/or case report forms; ensure data entered is correct and consistent with the source document and completed in a timely and organized manner. Utilize appropriate sources, gather and compile data, statistics and other materials as needed. Review data with supervisor and then provide reports to all parties (e.g., data and safety monitoring committee, the principal investigator, sponsoring agency, etc.) on the progress of the study. Review any issues that deviate from standard policy and procedure with supervisor. Compile data and assist in consolidating and analyzing data for presentation to sponsoring and regulatory agencies. Secure accurate signatures and forward documents and/or forms to the appropriate destination based on prescribed policies and procedures. Ensure protocol compliance, that is, that standard steps regarding eligibility criteria, follow-up, and required documentation is consistently followed in the time frame specified. Format and use tools to facilitate data collection (e.g., calendars, schedules, tracking logs, etc). Complete report forms and records following set protocol from the beginning of a research/ study through the end. Extract data for publications, or provide data collection from outside physicians offices. Secure accurate signatures and forward documents and/or forms to appropriate destination. Work with departments, labs, other personnel and areas as needed, to ensure the timely transfer of items and biological materials: study drugs; histology slides; serum, urine, blood samples, etc., using appropriate precautions at all times. Coordinate the shipment and transfer of varied types of materials among the various departments and labs. Gather, properly package, store and transfer slides, samples and other important materials. Duplicate and collate materials upon request. Complete filing in accordance with department procedures. Maintain 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. Record IRB approved subject study reimbursements according to standard operating procedures. Write template-defined progress notes that reflect study procedures. Provide material for and/or initiate IRB correspondence. Respond to requests in a timely manner, give/receive correct information, encourage required dialogue/follow-through. 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. Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records. Timely correction of queries. Aware of study regulatory status and keep an up to date copy of regulatory documents. Minimum Qualifications Associates degree plus one year related experience or equivalent combination of education and experience. Computer literate with good interpersonal, writing and verbal communication skills. Preferred Qualifications None. Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. We are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online. View Know Your Rights: Workplace discrimination is illegal. NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $53,294.22 - $57,750.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits. To view the Pay Transparency Notice, please click here #J-18808-Ljbffr NYU Langone Health