Associate Clinical Research Coordinator

NYU Langone Health; New York (NY); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Associate Clinical Research Coordinator to join their dynamic team. This role offers the chance to engage in groundbreaking oncology clinical research, ensuring compliance and patient safety while collaborating with a diverse group of professionals. As a key player in the coordination of clinical trials, you'll be involved in everything from recruitment and pre-screening to data collection and analysis. If you are passionate about contributing to medical advancements and thrive in a collaborative environment, this opportunity is perfect for you. Join a team that values diversity, equity, and inclusion, and make a meaningful impact in the field of healthcare.

Qualifications

• Bachelor's Degree or equivalent education/experience required.
• 2 years relevant experience with strong communication skills.

Responsibilities

• Coordinate oncology clinical research studies and ensure patient safety.
• Participate in recruitment and pre-screening activities for clinical trials.

Skills

Interpersonal Skills

Writing Skills

Verbal Communication

Problem Solving

Time Management

Education

Bachelor's Degree

Professional Certification (ACRP CCRC or SOCRA CCRP)

Tools

Microsoft Office (Word, Excel, Access, PowerPoint, Outlook)

EPIC EHR

Job description

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge.

Position Summary:

We have an exciting opportunity to join our team as an Associate Clinical Research Coordinator. The Non-therapeutic Oncology Associate Clinical Research Coordinator (NT aCRC) is an active participant in the coordination of oncology clinical research studies from research planning and throughout the conduct of clinical studies on various existing and upcoming protocols. The NT aCRC performs study coordination tasks under the direction of the principal investigator/treating investigator, under the supervision of CTO management/leadership and works closely with CTO staff, PCC staff, and other service rendering departments to ensure patient safety, overall compliance in the conduct of the study, adherence to the approved study protocol and quality clinical trial biospecimen and data collection. The NT aCRC interfaces directly with the Principal Investigators, various departments, research teams, and sponsors in support of the clinical trials as applicable.

Job Responsibilities:

• Participates in recruitment and pre-screening activities to identify diverse patients who may be eligible for clinical trials. This may include gathering information from the medical record, physician referral, advertisement, and scheduling visits to evaluate the patient/subject. Promptly follows up pre-screening requests and iConnect requests within 24 business hours.
• Collaborates with investigators, CTO staff and NYU/PCC staff to ensure a safe, compliant screening process by supporting seamless navigation of patients onto study from pre-screening, consenting, through the screening period and to eligibility. Supports thorough, efficient and safe screening research visit(s) under the direct supervision of the PI/investigator.
• Supports and conducts the informed consent process, if delegated, with the subject under the direct supervision of the PI/treating investigator, 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).
• Follows relevant institutional and departmental (e.g., NYU, OSR, IRB, & CTO) policies and standard operating procedures to ensure safe, compliant and quality research conduct.
• Registers/Randomizes subjects according to protocol and internal CTO policies.
• Demonstrates understanding of protocol elements and requirements. Develops tracking forms for all active trials, maintains tracking forms throughout the life cycle of the protocol and support a double check of tracking forms for patient safety and quality data acquisition.
• Provides updates to study team members regarding changes to workflow or patient-related needs according to protocol modifications.
• Communicates effectively with patients and assists them in understanding/navigating non-clinical study related concerns such as the schedule of events, trial related reimbursement or transportation, and ancillary services.
• Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinates subjects tests and procedures in compliance with the particular protocol and with the appropriate department.
• Prepares for upcoming study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, interpreter requests, facilitating tumor assessment form completion from the investigator, QOL, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support seamless, safe, and compliant clinical research conduct per protocol.
• Acts as a primary point of contact for all bio-specimen collections to include providing patients with specimen collection kits, collecting specimens, arranging for couriers, and coordinating tissue acquisition as required per protocol.
• Maintains basic knowledge of research study design and clinical research specimen collection procedures associated with clinical trials.
• Centrifuges, processes, prepares, ships and/or stores biological material in accordance with sponsor protocols, institutional standard operating procedures, Environmental Health and Safety requirements, and universal Biohazard precautions.
• Record, update, edit and maintain confidential information related to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner.
• Collects patient information for research project(s) to include, but not limited to: abstracting data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.), abstracting data for publications, or collecting data from outside physicians offices.
• Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies.
• Competency in utilizing CRMS and Research Navigator for day-to-day tasks.
• Schedules monitoring visits as needed.
• Maintains a working knowledge of active and pipeline clinical trials within the DMG and regularly updates the Non-therapeutic section of the DMG schema.
• Understands and coordinates the submission of adverse events per protocol and per institutional and FDA guidelines.
• Maintains trackers to ensure patients remain compliant with study specific requirements and tasks.
• Compiles and submits weekly patient lists to RBMU and other departments as needed.
• May perform EKGs with documented training.
• Performs concomitant medication review including reconciliation of the medication list.
• Maintain a clear, clean follow up calendar for the CCU DMG team ensuring all survival follow up assessments are completed per the protocol.
• Conducts a protocol feasibility assessment per institutional guidelines.
• Attends DMG and CTO meetings to support patient care, quality research conduct.
• Demonstrates competence in Good Clinical Practice (GCP) guidelines, Federal Regulations that govern and conduct human subjects research and the NYU IRB policies and procedures related to Human Subjects research.
• Responsible for quality source documentation following ALCOA-C standards.
• Protects patient confidentiality and PHI and complies with HIPAA.
• Demonstrates self-auditing of own work to ensure protocol compliance and patient safety.
• Utilizes principles of HRO in day-to-day work and communication to ensure safe, quality clinical research conduct.
• Supports internal audits and preparation for external audits as needed across the CTO.
• May write research notes in EPIC to support clear clinical trial documentation.
• Coordinates the submission of imaging with the Department of Radiology.
• Performs other duties as assigned and additional responsibilities as needed including but not limited to cross-covering other CCU DMGs as needed.

Minimum Qualifications:

To qualify you must have a Bachelor's Degree or equivalent combination of education and experience required. Computer literate with good interpersonal, writing and verbal communication skills.
2 years relevant experience required. Effective oral, written, communication, interpersonal skills. Must be able to work under the direction of supervision Ability to identify, analyze and solve problems. Time management skills and ability to work well under pressure. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, PowerPoint and Outlook. Familiar with Internet applications.

Preferred Qualifications:

Bachelors degree, preferably in science, public health, health education or a related field. Professional certification (ACRP CCRC or SOCRA CCRP). Individuals without this certification will be encouraged to obtain this certification within one year of starting in the Associate CRC role. 1-2 years experience in research or related experience preferred. Experience in oncology setting preferred. Experience with EPIC EHR 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.

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.