Oncology Clinical Research Coordinator III

Posting Summary
Rutgers The State University of New Jersey is seeking a Oncology Clinical Research Coordinator III within the Office of Human Research Services ( OHRS ) at the Rutgers Cancer Institute. The primary purpose of the Oncology Clinical Research Coordinator III position is to assist Rutgers Cancer Institutes multidisciplinary Disease Specific Group ( DSG ) Clinical Research Teams with conducting clinical trials. This role is responsible for assisting the clinical research team in overall study coordination including but not limited to preparing for study initiation and activation acquisition of source documents record maintenance preparing study documents patient registration coordinating and data entry. The Oncology Clinical Research Coordinator III serves as a study liaison with study sponsors and provides assistance with overall study coordination that is in compliance with the Food and Drug Administration ( FDA ) National Institutes of Health ( NIH ) Code of Federal Regulations ( CFR ) Good Clinical Practice ( GCP ) guidelines Office for Human Research Protection ( OHRP ) Health Insurance Portability and Accountability Act ( HIPAA ) institutional guidelines and standard operating procedures (SOPs) set forth by Cancer Institute of New Jersey and RBHS . Additionally the Oncology Clinical Research Coordinator III understands and meets/exceeds the needs of all customers (patients families study sponsors monitors auditors multidisciplinary team etc). Essential Duties and Responsibilities include the following: Works with the Protocol Activation Office to coordinate the initiation and activation of all new clinical trial protocols assigned. This includes but is not limited to verifying Scientific Review Board ( SRB ) Institutional Review Board ( IRB ) Human Research Oversight Committee ( HROC ) data collection plans and finance/contract approvals prior to study activation. Coordinates the preparation of study tools including but not limited to study binders medication diaries eligibility checklists and flow sheets (as required). Using OnCore/Excel/Word develops study tools including but not limited to eligibility checklists medication diaries calendars and flow sheets (as required). In collaboration with the Research Nurse Clinician ( RNC ) and/or physician reviews patients charts and medical history to confirm protocol eligibility and obtains source documents (i.e. medical record documentation) as needed. Under the direction of the RNC and/or physician ensures that IRB approved informed consent has been obtained signed placed in the medical record and that a copy was provided to the patient. Registers consented research patients with study sponsor (e.g. industry NCI Cooperative group etc.) and inputs into the OnCore clinical trials database maintained by the Cancer Institute of New Jersey. Coordinates the clinical assessments and patient care of study participants including but not limited to screening and evaluation of study participants with ancillary departments (such as pathology radiology clinical laboratory surgery infusion services) within the Cancer Institute as per protocol requirements. Maintains research record (e.g. patient consent eligibility registration confirmation corresponding source documents etc.) for all patients enrolled in Cancer Institute of New Jersey clinical trials across the health collaboration with the RNC and physician assists with grading adverse events using the most recent version of National Cancer Institute ( NCI ) common toxicity criteria or protocol specific grading scales. Completes Serious/Unexpected Adverse Event ( SAE ) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors federal requirements and institutional guidelines. Ensures research record (e.g. patient consent eligibility CRFs registration confirmation corresponding source documents etc.) is maintained for all patients enrolled in Cancer Institute of New Jersey clinical trials across the health system. Enters data as directed by data capture plan ( DCP ) into various auditable databases or electronic data capture systems and/or oversees data entry and validation to ensure accuracy of data. Supports data management process by addressing queries from monitors. Collaborates with BRS and/or OHRS research staff members to ensure procurement of protocol specific bio-specimens (e.g. blood urine and tissue) are collected and processed according to protocol specific guidelines. Performs other related duties as assigned.

Overview
RUTGERS CANCER INSTITUTE VISION MISSION AND CORE VALUES : VISION : Through our science our evidence-based actions our openness and our respect for those we serve we will advance cancer-focused research worldwide and reduce the burden of cancer in our catchment area. By engaging with and empowering our exceptionally diverse populations and addressing their questions and fears we will engender hope for cancer patients and their families and play a critical role in strengthening the fabric of our communities by gaining and protecting their trust and providing access to the outstanding oncology care each person deserves. MISSION : Our mission is to accelerate scientific discovery focused on understanding cancer innovating cancer treatment and improving cancer prevention; to provide outstanding novel and compassionate patient care; to provide evidence-based and culturally informed education to physicians nurses researchers staff and the community; and to achieve cancer health equity in our state through outreach to and engagement of our extraordinarily diverse communities. CORE VALUES : Curiosity and Discovery : encouraging an environment of continuous inquiry creativity and innovation to generate new knowledge Integrity : earning the trust of those we serve and each other through honesty transparency accountability and continuous reflection Collaboration : approaching all opportunities with an understanding that together we are better and can achieve more; promoting and maintaining an environment of teamwork and shared knowledge Respect and Caring : consistently demonstrating caring compassion and respect through our words and actions Perseverance : maintaining an unwavering commitment to our mission; embracing change overcoming obstacles and creating and recreating the path to achieve our goals

Preferred Qualifications
Masters Degree preferred Understanding of the software program Oncology Collaborative Research Environment (OnCore) is preferred.