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Position Summary:
We have an exciting opportunity to join our team as a Senior Research Coordinator.

In this role, the successful candidate will be responsible for initiating, coordinating and managing clinical research studies conducted at the Transplant Institute as well as Xenotransplant initiatives (living and brain-dead decedent). Oversees the financial and protocol development for assigned studies, Assists with managing the recruitment process, enrollment, research data collection and study coordination activities. Performs intra-operative 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, HIPPA, and required obligations to patient/subject, Principal Investigator (PI), research team and Sponsor. Provides guidance to Research support staff. Interfaces directly with patients/subjects and PI in support of the clinical trials as applicable. Works autonomously and with limited oversight. Establishes 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. Works under general direction. Maintains CRC certification requirements and position requirements set forth by NYU Langone Health.

Job Responsibilities:

• Demonstrates knowledge of the organization's core values and incorporates them into the performance of duties.
• Study Regulations: Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists and performs 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. Monitors any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Reminds patients/subjects of visits and compliance in a consistent manner.

• 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 physicians 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 willingness to participate in the study.
• Clinical Competency: 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. 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.
• 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., 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.

• Reporting and Analysis: Researches, compiles and consolidates data and conducts preliminary analysis 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. Recommend changes/additions to established data fields. Formulates, prepares database and generates preliminary measurement reports for review by the PI or Director. 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. May oversee staff assigned to this responsibility.

• Project Leadership Oversees planning/management of study activities and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives.

• Recruitment Manages the recruitment process for study/program. 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,

• Financial Development: Develops a draft and final budgets in conjunction with budget specialist assigned to the Transplant Institute for submission to the Supervisor/Principal Investigator. Monitors budget throughout trial and recommends staffing levels based on reviewed protocol. 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. Might identify new potential sponsors/agents for trials, researches and participates in the development of protocols as assigned.

• Decision Making and Problems 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 non-solved issues and questions with recommendation to supervisor.

• Judgment/Decision-Making: Able to recognize problems as they occur; and through the application of appropriate policy/ procedure, determines and/or recommends 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 Medical Center. Listens carefully to others in-order to respond appropriately, answer questions or obtain needed information. Communicates ideas, problems, suggestions, and messages in a timely and effective manner. Maintains the confidentiality of all research information.

Additional Position Specific Responsibilities:
Other Responsibilities: 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 organizations Core Values and incorporates them into the performance of duties. Participates in special projects and performs other duties as required.
Provides guidance, training, leadership to less experienced staff. May have input into staff evaluations.
Participates in special projects and performs other duties as assigned.

Minimum Qualifications:
To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of four years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, 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. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. 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.
1. To qualify you must have a Bachelors degree or equivalent in business administration, health care administration or related field.
2. Minimum of four years of progressively responsible clinical research project coordination experience, preferably in an academic health care setting.
3. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications.
4. Effective oral, written, communication, interpersonal skills.
5. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers.
6. Ability to work within a team environment as well as independently.
7. Commitment to continuous learning as required by department administration.
8. Ability to operate research related equipment.
9. Ability to work and make decisions independently.
10. Time management skills and ability to prioritize tasks.
11. Ability to identify, analyze and solve problems; Ability to work well under pressure.
12. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials.
Preferred Qualifications
1. Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).
2. Knowledge of basic medical terminology is preferred.
3. Experience working in an Academic Medical Center preferred.

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. At NYU Langone Health, 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. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

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.

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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 $70,727.81 - $91,104.61 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.

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