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Position Summary:
We have an exciting opportunity to join our team as a Research Coordinator, Part-Time.
Responsible for providing moderate to advanced range of coordination of a randomized placebo-controlled research study conducted at the Medical Center exploring the use of GLP1 agonists for the treatment of opioid use disorder. Will be responsible for development of local Standard Operating Procedures and later initiation and management of the study.
Will assist with the recruitment, enrollment, retention, grant submissions, research data collection and study coordination activities.
Performs intra-study monitoring and serves as liaison with internal and external funding agencies.
Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and required obligations to patient/subject, Principal Investigator, Research Team and sponsor.
Interfaces directly with patients/subjects and Principal Investigator in support of the clinical trial by conducting research visits, scheduling and ensuring regular follow-up, and recruiting future patients/subjects.
Establishes and maintains liaisons with relevant parties at the Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems and regulatory Services.
Initiation and management of research studies.
Job Responsibilities:
Human Subjects' Research - As applicable, oversee the submission of necessary documents required by the NYU 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., ensures 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 timely manner, as necessary.
Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists with the informed consent process and ensure 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.
Data Management - 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); abstraction of data for publications, or data collection from
outside physician offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports. Conducts study visits, obtains and documents information within the time frame specified.
Budget - Develops a preliminary draft budget and submit to the Director/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 helps identify new potential sponsors/agents for trials and researches.
Monitors budget throughout trial.
Decision Making and Problem Solving - Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations and refers unsolved issues and questions with recommendation to supervisor.
Recruitment Works with local recruiting partners and develop relationships with new recruiting partners to recruit participants. 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 willingness to participate in the study.
Retention Work with study team to keep participants engaged in study protocol and procedures. Gather information about participants to help locate them if they are lost to follow up. Use this information to locate participants and encourage them to return to study participation.
Clinical Competency - competency in performing urine testing, 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. Other trainings and competencies may be included as required.
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 area of practice. Maintains annual requirement of 10 CEUs in continuing research education; 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.
Reporting and Analysis - Researches, compiles and consolidates data and conducts preliminary analyzes to 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); continues to follow-through with items and patients as part of the research study.
Grants - Prepares and submit grant applications and other grants related an activity 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.
Participates in special projects and performs other duties as required.
Minimum Qualifications:
To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related field.
Minimum of two years of progressively responsible project coordination experience, preferably in a research setting.
Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications.
Effective oral, written, communication, interpersonal skills.
Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers.
Ability to work within a team environment as well as independently.
Commitment to continuous learning as required by department administration.
Ability to operate research related equipment
Ability to work and make decisions independently.
Time management skills and ability to multitask.
Ability to identify, analyze and solve problems: Ability to work well under pressure.
Preferred Qualifications:
Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical terminology is preferred. Experience working in an Academic Medical Center preferred. Experience working with people with substance use disorders.
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. 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 Grossman 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 Grossman 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.
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 $34.28 - $36.00 Hourly. 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
Required Skills
Required Experience