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We have an exciting opportunity to join our team as a Research Data Associate.
In this role, the successful candidate is responsible for providing direct data and/or clinical research in 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.
- Write template-defined progress notes that reflect study procedures.
- Record IRB approved subject study reimbursements according to standard operating procedures.
- Provide material for and/or initiate IRB correspondence.
- Aware of study regulatory status and keep an up to date copy of regulatory documents.
- Timely correction of queries.
- Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records.
- 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.
- Secure accurate signatures and forward documents and/or forms to appropriate destination.
- 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.
- Completes filing in accordance with department procedures.
- Duplicates and collates materials upon request.
- Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study.
- Recruitment capabilities and the screening of potential patients/subjects for eligibility to the study.
- Assist with the informed consent process.
- Review all the elements of the screening process with the Principal Investigator.
- Collaborate with various personnel that may be involved in assisting with specific aspects in the study.
- Interact with patient/subject and families in a courteous and professional manner.
- 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 study visits, obtain and document information within the time frame specified.
- Monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse.
- Works with the principal investigators and research nurses on monitoring the overall conduct of the study.
- Works with the research nurses in reporting adverse events to the appropriate regulatory bodies as instructed.
- Tracks study milestones and patient accruals to help evaluate the progress of studies.
- Acts as internal auditors during quarterly internal audits for other studies.
- Reviews data with supervisor and provides reports to the data and safety monitoring committee.
- Gathers, Properly Packages, Stores and Transfers Slides, Samples and Other Important Materials.
- Coordinates the shipment and transfer of varied types of materials among the various departments and labs.
- 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.
- Responds to requests in a timely manner, gives and receives correct information, encourages required dialog and follow through.
- Follow-ups to ensure that requested materials are delivered according to all appropriate procedures and policies.
- Collects, prepares, ships, and/or stores biological materials using universal precautions.
- 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.
- 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 (if proper training has occurred) draw patients/subjects blood, perform EKG, and or take vital signs.
- May be required to travel to study initiation (that is, where sponsor teaches protocol to PI and CRC).
- Utilizes the necessary tools to ensure protocol compliance to conduct direct data research.
- Utilizes established methodologies to collect patient information for the research project(s).
- Extracts data for publications, or provides data collection from outside physicians offices.
- Formats and uses tools to facilitate data collection (e.g., calendars, schedules, tracking logs, etc).
- Ensures protocol compliance, that is, that standard steps regarding eligibility criteria, follow-up, and required documentation is consistently followed in the time frame specified.
- Secures accurate signatures and forwards documents and or forms to the appropriate destination based on prescribed policies and procedures.
- Compiles data and assists in consolidating and analyzing data for presentation to sponsoring and regulatory agencies.
- Reviews any issues that deviate from standard policy and procedure with supervisor.
- 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.
- Completes report forms and records following set protocol from the beginning of a research/study through the end.
- Utilizes appropriate sources, gathers and compiles data, statistics and other materials as needed.
- 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.
- Suggests changes and additions to established data fields as needed, to supervisor.
- Processes incoming and outgoing documents by transcribing data, figures, statistics, codes and other information.
- Completes paperwork and forms in a neat, accurate, timely manner and ensure subsequent data collection as required.
- Maintains copies of all required on-going documentation and forms for the files.
- Reviews data to be entered, edits obvious errors and obtains missing information.
- Prepares requested data and numbers thoroughly and accurately for statistical analyses and required reporting.
- Ensures that information in computer database is accurate, entered and maintained on a timely basis.
- May perform library searches and retrieve reference materials from various sources using Medline and PubMed.
- May request articles from medical journals.
- May prepare presentation for lectures and symposium, utilizing PowerPoint for slides.
- Coordinates, Facilitates and Communicates with Staff and Non-Staff to Produce Required Results.
- Interfaces with varied persons, such as, School of Medicine and or Medical Center staff (e.g. physicians, nurses, CTO).
- 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.
- Works with research nurses as part of a team to coordinate clinical trials.
- Demonstrates knowledge of and follows proper clinical study processes within current policies and procedures.
- Recognizes and identifies problems, appropriately escalate issues to supervisor as needed.
- Utilizes available resources and established procedures in order to rectify problems, communicates all changes.
- Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visit.
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.
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.
Position Summary:Responsible for providing direct data and/or clinical research in 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.
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.