Associate Clinical Research Coordinator - Cancer Center

NYU Langone Health is hiring an Associate Clinical Research Coordinator for cancer-related clinical research studies. The role coordinates study activities and patient visits, manages research biospecimen collection and processing, and supports protocol compliance, laboratory operations, and study feasibility.

Responsibilities

• Work with licensed clinicians to develop tracking forms for all active trials, maintain tracking forms throughout the life cycle of the protocol
• Provide updates to study team members regarding changes to workflow or patient-related specific needs according to protocol modifications
• Schedule participants according to the approved protocol; coordinate with ancillary service providers to ensure patients remain adherent to the protocol
• Prepare for study visits: bio-specimen collection, research ticket preparation, lab and EKG orders, scheduling of biopsies and scans, facilitating RECIST form, AE and Conmed form completion in conjunction with licensed professional and other tasks as needed
• Act as primary point of contact for all bio-specimen collections
• Compile and submit weekly pharmacy lists to investigational pharmacy
• Monitor infusion chair assignments; assure patient assignments are aligned with protocol requirements; make necessary requests for changes on as-needed basis
• Help to reconcile any clinical discrepancies in data with RDAs and RCs
• Maintain follow up calendar ensuring all survival follow up assessments are completed per the protocol; performs assessments not requiring licensure
• May perform EKGs with documented training
• Initiates vial assignment by DCU and coordinates with Infusion Nurses and Pharmacy to ensure timely dispensation of IP
• Participates in Pre-Screening activities to identify patients that may be eligible for a clinical trial
• Under the supervision of licensed clinicians administers ancillary assessments (i.e, Quality of Life Exam)
• Participates in the feasibility and complexity assessment process for new protocols
• 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)
• Under the supervision of investigator, may take part in AE and Con Med documentation and reporting activities such as Serious Adverse Events (SAE) and Events of Clinical Interest (ECI) reports (all documentation must be verified and signed by licensed clinicians before submission and all assessments must be made by a licensed clinician). Write research notes in EPIC (may not make assessments)
• Helps compile enrollment packet materials (must be reviewed and signed by the CRN and investigator)
• Facilitate collection of biofluid research specimens for clinical trials by providing clinical collection materials to study team personnel and/or infusion nursing as indicated
• Maintain basic knowledge of research study design and clinical research specimen collection procedures associated with clinical trials. Understands the principles of most research tests performed in research clinical trials
• Complete necessary Biological Hazard training provided for the proper handling and collection of biological substances and the packaging and shipment of human biofluid samples
• Respond to requests for clinical collection materials in a timely manner, give/receive correct information, encourage required dialogue/follow-through. Utilize available resources and established procedures to identify problems for quick resolution
• Maintain clean laboratory facilities and shared bench spaces. Work with teammates to share general laboratory responsibilities
• Monitor transport and receipt of collected research biofluid samples on a daily basis
• Centrifuge, process, prepare, ship and/or store biological material in accordance with sponsor protocols, institutional standard operating procedures, Environmental Health and Safety requirements, and universal Biohazard precautions. Perform bench work as needed, perform advanced specimen processing techniques under direct supervision
• Manage study specimen inventories and clinical biospecimen collection supply inventories for multiple studies at the same time
• Under direct supervision, collaborate with various NYU School of Medicine and Hospital personnel involved in assisting with specific aspects of each study that may include: Research Nurses, Infusion Nurses, Phlebotomists, Program Managers
• Regulatory staff and collaborating NYU Laboratories
• May attend site-initiation visits and monitoring visits in relation to protocol specimen requirements in addition to clinical research coordinator duties
• 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 and ensure subsequent data collection as required. Complete timely correction of queries stemming from inappropriately reported and/or recorded specimen data or missing specimens. Initiate prompt specimen data correction or submission if needed
• Maintain complete and accurate specimen collection records utilizing enterprise databases for all specimens handled and distributed. Maintain biospecimen files in an organized and up-to-date manner in order to facilitate their retrieval and maintain copies of all required on-going documentation and forms for the files
• Perform all responsibilities in accordance with institutional and CTO Standard Operating Procedures, CAP accreditation, established guidelines, work instructions and appropriate industry and Good Clinical Practice standards
• Supports pre-screening as needed for potential patients, and collaborates with other CRC across the CCU to support pre-screening and navigating patients to study
• Performs additional duties as necessary including but not limited to: the development of SOPs, policy changes, education sessions, and quality improvement projects
• Responsible for biospecimens collection, processing, storage, and distribution for clinical trials, biobanks and research studies
• Responsible for specimens inventory and QC prior distribution
• Responsible for specimens data entry in database (LabVantage/FileMaker Pro
• Responsible on consenting patients for research studies
• Assists Research Coordinator in repository audits
• Performs bench work as needed
• Provides support to CBRDs central lab: clinical trials feasibility reviews, site initiation meetings, trainings
• Provides support on drafting Standard Operating Procedures and/or work instructions
• Assists on data entry for monthly billing on research and clinical studies
• Maintains a clean, orderly work area within the laboratory
• Performs all responsibilities in accordance with Standard Operating Procedures, CAP accreditation, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards

Preferred

• Prior experience working with centrifuges and handling biofluid specimens is preferred
• Bachelors degree, preferably in science, public health, health education or a related field
• Professional certification (ACRP CCRC or SOCRA CCRP)
• Centrifuge Operation
• Biofluid Specimen Handling
• Bachelor’s Degree in Science
• Public Health
• ACRP CCRC Certification
• SOCRA CCRP Certification

Benefits

• Financial security benefits
• A generous time-off program
• Employee resource groups for peer support
• A holistic employee wellness program focused on physical, mental, nutritional, sleep, social, financial, and preventive care

Company

• Integrated academic health system for patient care, education, and research
• New York, New York, USA
• https://nyulangone.org/
• Founded in 1841
• 10001+ employees

Qualifications

• Bachelor's degree or equivalent combination of education and experience required
• Computer literate with good interpersonal, writing and verbal communication skills
• 1 year of relevant experience required either as a research coordinator with biospecimen processing or laboratory experience or clinical experience
• Strong time management skills and ability to work well under pressure and deadlines
• Effective oral, written, communication, interpersonal skills
• Must be able to work and make decision in a team setting and independently under direction of a supervisor
• Ability to identify, analyze and solve problems
• Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook
• Familiar with Internet applications
• Intermediate competency in medical terminology, and an advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research
• Qualified candidates must be able to effectively communicate with all levels of the organization
• Prior experience working with centrifuges and handling biofluid specimens is preferred
• Bachelors degree, preferably in science, public health, health education or a related field
• Professional certification (ACRP CCRC or SOCRA CCRP)

Required skills

• ACRP CCRC, Biofluid Specimen Handling, Biospecimen Processing, Centrifuge Operation, Clinical Practice (GCP), Clinical Research Coordination, Human Subjects Research Regulations, Institutional Review Board (IRB), Medical Terminology, Microsoft Office, SOCRA CCRP

Preferred skills

• Professional certification (ACRP CCRC or SOCRA CCRP)

Experience

• 1+ years