Senior Research Coordinator

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

The Ophthalmology Senior Clinical Research Coordinator (Sr.CRC) is an active participant and CRC team leader in the coordination of Ophthalmology related clinical research studies from research planning to conduct IRB-approved clinical trials and research studies, training CRCs and developing research and auditing policies for the Ophthalmology Department. The Ophthalmology Sr.CRC performs study coordination tasks under the direction of the Principal Investigator (PI) and under the supervision of the Senior Research Manager and works closely with the Ophthalmology clinical staff to ensure patient safety, overall compliance in the conduct of the study, adherence to the IRB-approved study protocol and quality clinical research data collection. The Ophthalmology Sr.CRC is a critical contributor and team member to support the Ophthalmology Departments research mission.

Job Responsibilities:

Demonstrates an in-depth understanding of and compliance with institutional and department policies and standard operating procedures such as relevant NYU, OSR, IRB and CTO policies, procedures and SOPs to ensure safe, compliant and quality research conduct. Supports the education and training of CRCs in these tasks.

Proficient understanding of protocol elements and requirements, supports the

education and training of other clinical research team members on such elements and requirements. Leads collaborative efforts with CRCs and CRNs to develop tracking forms for all active IRB-approved clinical trials and research studies, maintain tracking forms throughout the life cycle of the protocol and support an audit of tracking forms for patient safety and quality data acquisition. Performs study specific procedures and tasks under the supervision of the PI/Treating investigator and in collaboration with the research team, serves as a team leader to ensure patients on study are managed in a safe and compliant manner per the protocol.

Expert in all recruitment and pre-screening activities identifying diverse patients who may be eligible for IRB-approved research studies and clinical trials. Collaborates with other departments and research teams. Supports the training and mentorship of CRCs in learning these tasks.

Collaborates with PIs, Department faculty and Leadership staff to ensure a safe, compliant screening process by supporting seamless navigation of patients onto study from pre-screening, consenting, screening and to study eligibility. Supports thorough, efficient and safe screening research visit(s) in collaboration with all research team members and under the direct supervision of the PI. Is proficient in supporting a safe and compliant eligibility process, following internal and external standard operating procedures (SOPs)/policies and ensuring a timely, accurate and complete eligibility packet for the PI/Sib-I review and sign-off. Trains and educates CRCs on these tasks.

Supports the informed consent discussion with the subject under the direct supervision of the PI and/or in collaboration with the research team and clinical staff including but not limited to the study schedule of events, event reporting requirements, the use of the IRB, study related reimbursement etc. (Assessment and medical/nursing education must be performed by a licensed clinician). Supports the training of CRCs in these tasks.

Provides timely and complete updates to study team members regarding changes to workflow or patient-related specific needs according to protocol modifications. Ensures that all specific study calendars are up-to-date, accurate and consistent with protocol requirements to support safe team coverage and communication. Trains CRCs on these tasks.

Communicates effectively and clearly with patients and investigators about non-clinical study related concerns such as the schedule of events, trial related reimbursement or transportation. Demonstrates a comprehensive understanding of the patients enrolled on clinical trial (active, follow up or survivorship) and maintain clear, accurate trackers within the unit to ensure compliant follow up. Trains CRCs on these tasks.

Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinates subject's tests and procedures in compliance with the particular protocol and with the appropriate department and collaborates with other NYU departments to seamlessly navigate a patient to a trial and through screening, treatment and follow up/end of treatment. Coordinates with ancillary service providers to ensure patients remain adherent to the protocol.

Ensures timely, accurate preparation for upcoming study visits per protocol including but not limited to research bio-specimen collection order preparation/placement, laboratory and EKG order placement, facilitating RECIST form completion from the investigator, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support the administrative conduct of clinical trials. Supports the training of CRCs for these tasks.

Maintains expert working knowledge of active and pipeline clinical trials and trackers to ensure patients remain compliant with study specific requirements and tasks within the DMG and regularly updates the DMG schemas. Oversees that the applicable DMG schema is maintained up-to-date on a monthly basis including AE, SAE, ECI, UADE, SUSAR and RNI. Trains CRCs on these tasks and supports their growth in these areas.

Acts as primary point of contact for all bio-specimen collections. Utilizes EPIC and LabVantage to complete research biospecimen orders in a timely manner for all studies. Assists patients in understanding the schedule of assessments according to the approved protocol, coordination of appointments, and ancillary services (under the supervision of a licensed clinician but clinician does not have to be physically present).

Compiles and submits weekly patient treatment lists to investigational pharmacy and RBMU and other departments as needed.

Performs medication review including reconciliation of the medication list, verification of drug/dose taken and diary review if applicable, appropriate documentation in EPIC and via the study specific diary following SOP under the direction of the investigator or in collaboration with a licensed RN/APP. Trains CRCs for this process.

Supports internal audits and preparation for external audits as needed. Self-audits one's own work to ensure protocol compliance and patient safety. Supports, contributes and takes initiative to resolve protocol/sponsor related concerns and discrepancies.

Expertly conducts a protocol feasibility assessment per institutional guidelines and utilizing CTO specific resources and guidance documents. Appropriately escalates and informs management and leadership of feasibility barriers for protocols under review. Oversees study activation to ensure that all necessary elements are in place for a safe, compliant study.

Takes the lead on reconciling clinical discrepancies and queries in a timely manner in collaboration with team members in learning how to complete queries.

Demonstrates competence in Good Clinical Practice (GCP) guidelines, Federal Regulations that govern and conduct human subject's research and the NYU IRB policies and procedures related to Human Subject's research. Perform study operational activities and tasks in compliance with GCP, Federal Regulations and institutional policies and procedures. CCRP/CCRC certification required for promotion to this role.

Responsible for quality source documentation following ALCOA-C standards (attributable, legible, contemporaneous, original, accurate and complete) and compliant with CTO specific documentation. Protects patient confidentiality and PHI and complies with HIPAA. Respectfully reconciles clinical or data discrepancies with team members. Oversees deviation tracking and collaborates with management to address and prevent deviations. Writes research notes in EPIC to support clear clinical trial documentation (may not make assessments).

Proficient in utilizing CRMS and Research Navigator for day-to-day tasks: including but not limited to always checking that participating PIs/Sub-Is and staff are listed on study with the IRB prior to upcoming clinical trial visits/activities. Serves as a super-user for the team.

Engages in problem solving and generating solutions to barriers and opportunities for improvement. Serves as a team leader and peer-mentor supporting management in tasks or responsibilities including the training and development of CRCs.

Performs other duties as assigned and additional responsibilities as needed including but not limited to helping with the development of SOP's, policy changes, education sessions, and quality improvement projects across the CTO and in collaboration with other units and departments

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.

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 - $85,000.00 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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