Aware of study regulatory status and keep an up-to-date copy of regulatory documents. Assists with the informed consent process and ensures 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.
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.); the abstraction of data for publications, or data collection from outside physician's offices. Audits and manages data from and into the database. Prepares forms and reports compiles 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 the event, and the patient/subject's willingness to participate in the study.
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. A continuous Learning Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in research role and maintains current expertise in the area of practice. Maintains annual requirement of 10 CEUs in continuing research education; the employee must demonstrate proof of ongoing research education. Serves as a resource to peers and works collaboratively with other disciplines within the area of expertise.
Human Subjects Research
As applicable, oversee the submission of necessary documents required by the NYU Grossman 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., ensure 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 a timely manner, as necessary.
Reporting and Analysis
Researches, compiles, and consolidates data and conducts preliminary analyzes of 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); continue to follow through with items and patients as part of the research study.
Prepares and submits 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.
Develops a preliminary draft budget in conjunction with the budget specialist assigned to Surgery and submits it to the Supervisor/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 help identify new potential sponsors/agents for trials and research. Monitor budget throughout the trial.
Decision Making and Problems Solving
Combines and evaluates information and data to make decisions about the relative importance of information and choose the best solution to solve problems. Resolves complex situations and refers to non-solved issues and questions with recommendations to the supervisor.
Able to recognize problems as they occur; and, through the application of appropriate policy/ procedure, determine and/or recommend the appropriate solution. Seeks guidance as necessary for the performance of duties, asks appropriate questions when in doubt, and utilizes reference sources/materials to endure accuracy. Advises appropriate personnel of situations/problems requiring intervention or follow-up attention.
Communication/Relationship with Others
Cooperates communicates and relates well to all levels of the Medical Center. Listens carefully to others in order to respond appropriately, answer questions or obtain needed information. Communicate ideas, problems, suggestions, and messages in a timely and effective manner. Maintains the confidentiality of all research information.
May provide students with technical guidance and direction in the operation of various sample preparation techniques, extraction lines, and equipment as well as general laboratory practices and safety protocols. Ensures timely and accurate completion of research projects. Demonstrates knowledge of the organization's Core Values and incorporates them into the performance of duties. Participates in special projects and performs other duties as required.