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NYU Langone Hospital-Long Island is a 591-bed university-affiliated medical center, which offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. We are a major regional healthcare resource with a deep commitment to medical education and research, offering a full complement of inpatient and outpatient services.
Position Summary:We have an exciting opportunity to join our team as a Clinical Research Coordinator - Cancer Center Clinical Trials. The Clinical Research Coordinator (CRC) is an active participant in the coordination of cancer related clinical research studies from research planning to completion of studies. The Clinical Research Coordinator performs study coordination tasks under the direction of the investigator and works closely with the Research Nurse, other CRCs and the collaborating CTO units for the Disease Management Group(s) to ensure overall compliance in the conduct of the study and adherence to the approved study protocol. The CRC supports the management of the research biospecimen/biofluid components of clinical research studies, performs accurate execution of research protocols in accordance with PCC CTO Research Biofluids Management Unit (RBMU) standard operating procedures, Good Clinical Practice, HIPAA and required obligations to the patient/subject, Principle Investigator, clinical research team and the sponsor. The CRC assists with general laboratory cleanliness and organization, oversees and maintains a safe, organized inventory system for the clinical trial kit supplies and manages distribution and pick-up of clinical specimen kits to the necessary NYULI locations. The CRC directly interfaces with the research team and sponsor-contracted third-party laboratories in support of the clinical trials, and supports evaluation of feasibility and addresses workability concerns to ensure safe, timely activation of studies.
Job 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 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 SOP’s, policy changes, education sessions, and quality improvement projects
Minimum Qualifications:Bachelor's Degree or equivalent combination of education and experience required.Computer literate with good interpersonal, writing and verbal communication skills.Experience:2 years relevant experience required either as a research coordinator with biospecimen processing or laboratory experiencePrior experience working with centrifuges and handling biofluid specimens is preferredStrong time management skills and ability to work well under pressure and deadlinesEffective oral, written, communication, interpersonal skillsMust be able to work and make decision in a team setting and independently under direction of a supervisorAbility to identify, analyze and solve problemsKnowledge, Skills and Abilities:Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applicationsIntermediate 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.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 obtain this certification within one year of starting in the CRC role. 3 years experience in research or related experience preferred.
Qualified candidates must be able to effectively communicate with all levels of the organization.NYU Langone Hospital-Long Island 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 Langone Hospital-Long Island 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 Langone Hospital-Long Island'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. To view the Pay Transparency Notice, please click here.
Vacancy expired!