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Position Summary: We have an exciting opportunity to join our team as a temporary Research Data Associate (TP) through the NYU Langone In House Temp Program.
In this role, the successful candidate will be responsible for providing direct data and/or clinical research support of clinical trials, studies, and general research under direct supervision. Works with School of Medicine and Medical Center staff and departments, including Directors, Managers, Clinical Information Systems, Research Nursing and Regulatory Services; may also interfaces with patients and their families
Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visit.
Utilizes available resources and established procedures in order to rectify problems, communicates all changes.
Recognizes and identifies problems, appropriately escalate issues to supervisor as needed.
Demonstrates knowledge of and follows proper clinical study processes within current policies and procedures.
Works with research nurses as part of a team to coordinate clinical trials.
Initiates and continues regular contact with patients; encourages visit reminders and compliance to research; ensures contact with patients and their families is courteous, effective, professional and cooperative.
Interfaces with varied persons, such as, School of Medicine and or Medical Center staff (e.g. physicians, nurses, CTO).
Coordinates, Facilitates and Communicates with Staff and Non-Staff to Produce Required Results.
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.
Ensures that information in computer database is accurate, entered and maintained on a timely basis.
Prepares requested data and numbers thoroughly and accurately for statistical analyses and required reporting.
Reviews data to be entered, edits obvious errors and obtains missing information.
Maintains copies of all required on-going documentation and forms for the files.
Completes paperwork and forms in a neat, accurate, timely manner and ensure subsequent data collection as required.
Processes incoming and outgoing documents by transcribing data, figures, statistics, codes and other information.
Suggests changes and additions to established data fields as needed, to supervisor.
Inputs clinical and non-clinical data into the database and or case report forms; ensures data entered is correct and consistent with the source document and completed in a timely and organized manner.
Utilizes appropriate sources, gathers and compiles data, statistics and other materials as needed.
Completes report forms and records following set protocol from the beginning of a research/study through the end.
Reviews data with supervisor and then provides reports to all parties (e.g., data and safety monitoring committee, the principal investigator, sponsoring agency, etc.) on the progress of the study.
Reviews any issues that deviate from standard policy and procedure with supervisor.
Compiles data and assists in consolidating and analyzing data for presentation to sponsoring and regulatory agencies.
Secures accurate signatures and forwards documents and or forms to the appropriate destination based on prescribed policies and procedures.
Ensures protocol compliance, that is, that standard steps regarding eligibility criteria, follow-up, and required documentation is consistently followed in the time frame specified.
Formats and uses tools to facilitate data collection (e.g., calendars, schedules, tracking logs, etc).
Extracts data for publications, or provides data collection from outside physicians offices.
Utilizes established methodologies to collect patient information for the research project(s).
Utilizes the necessary tools to ensure protocol compliance to conduct direct data research.
May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC).
May (if proper training has occurred) draw patients/subjects blood, perform EKG, and or take vital signs.
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.
Attends 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.
Collects, prepares, ships, and/or stores biological materials using universal precautions.
Follow-ups to ensure that requested materials are delivered according to all appropriate procedures and policies.
Responds to requests in a timely manner, gives and receives correct information, encourages required dialog and follow through.
Works 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.
Coordinates the shipment and transfer of varied types of materials among the various departments and labs.
Gathers, Properly Packages, Stores and Transfers Slides, Samples and Other Important Materials.
Reviews data with supervisor and provides reports to the data and safety monitoring committee.
Acts as internal auditors during quarterly internal audits for other studies.
Tracks study milestones and patient accruals to help evaluate the progress of studies.
Works with the research nurses in reporting adverse events to the appropriate regulatory bodies as instructed.
Works 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.
Recruitment capabilities and the screening of potential patients/subjects for eligibility to the study.
Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study.
Duplicates and collates materials upon request.
Completes 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.
Secure accurate signatures and forward documents and/or forms to appropriate destination.
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.
Provide material for and/or initiate IRB correspondence.
Record IRB approved subject study reimbursements according to standard operating procedures.
Write template-defined progress notes that reflect study procedures.
Minimum Qualifications: To qualify you must have an Associate's 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 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: 65943419
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.