Description: SUMMARY STATEMENT Participate in all research activities as part of the clinical research team located at team located at Santa Monica and Westwood while under the direction of the team leaders, investigators, Financial Administrative Office (FAO), Faculty Director, Medical Director, and Senior Research Director (Senior Management) of the JCCC CRU. The incumbent is responsible for completing in a timely and accurate manner the data management of clinical research studies, protocol related tasks, assisting with shipment of specimens, and administrative functions of the oncology research unit, according to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), Institutional Review Board (IRB) and government regulations. This includes responsibility for collection and transcription of research patient data and study related information into research records (Case Report Forms [CRFs]), and assists with maintenance of study patient files to fulfill research requirements. The incumbent is responsible for working with study monitors to process and collect accurate data in a timely manner and assist investigators and study coordinators in clinic settings. Work may be assigned by the manager, team leader, investigator or Senior Management. Assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner. Available occasionally to work flexible hours to meet study or CRU deadlines and priorities. TYPE OF SUPERVISION RECEIVED The incumbent is expected to independently prioritize assignments and complete ongoing tasks following established CRU procedures and regulatory guidelines. Incumbent will seek guidance from direct supervisor or Senior Management when there are conflicting demands. In addition, the reporting structure of this position may require the incumbent to report on matters to CRU administrative staff who may not be members of the home department for this position. Time reporting, requests for vacation and other similar matters will be addressed with the direct supervisor. A work performance evaluation will be undertaken on an annual basis. HOW LONG HAVE THE DUTIES & DISTRIBUTION OF TIME BEEN SUBSTANTIALLY AS BELOW? >2 years ATTACH A COPY OF MOST RECENT ORGANIZATION CHART AMOUNT OF TIME DUTIES AND TASKS 50% Clinical Trial Duties Prepare, process, and ship biological specimens, including liquid and tumor specimens. Obtain and handle dry ice for shipping specimens, obtain liquid nitrogen, and dispose of biohazardous material, laboratory kits, study equipment (i.e. EKG, Holter monitors, or glucose monitors), forms are received, stored and accessible to the research team. Assist Principal Investigators and research teams with the collection of patient records and source documents. Request outside records, tumor slides and blocks, images or any other necessary protocol require documentation. Prepare and track study laboratory or pathology specimens stored or shipped to central laboratories or facilities according to protocol requirements, and to ensure that they have been processed and received in an appropriate manner. Maintain accurate shipping records to ensure that specimens have been sent according to protocol requirements. Resolve any missing data and/or shipping issues regarding specimens with central laboratories or facilities and ensure that the specimens or tumor blocks have been returned to the originating site or facility if required. Ensure that if a patient has requested notification of outcome of testing or denies certain use of specimens, it is handled appropriately by the central testing facility and the originating site and physician. Resolve any missing data and/or shipping issues regarding specimens with central laboratories or facilities and ensure that the specimens have been returned to the originating site or facility if required. Attend study initiation meetings, and participate in study initiation and staff training events (teleconferences and/or meetings). Assist study team with training and orientation of clinic treatment staff regarding protocol requirements. 25% Clinical Trial Data Management Enter source data into the case report forms (CRF) in a timely and accurate manner and according SOP and CRF Completion Guidelines. Review and resolve data queries in a timely manner, according to the protocol/contract or SOP. Assist with communications (telephone calls and/or letters) with research participants active on study or in long-term follow up phase and provide accurate and timely documentation of all communications for the patient s source medical records and research charts. Prepare, review and maintain accurate, timely and complete research charts with original source documents and copies of all pertinent study records, making any necessary corrections to errors per SOP. Participate in interim monitoring visits (IMV) for source data verification (SDV). This may include, scheduling and coordinating IMV for assigned studies, working directly with monitors as needed in order to ensure timely SDV, CRF completion and query resolution. Notify study team members of any outstanding study compliance issues including deviations that are identified or additional data deadlines that arise from monitoring and/or auditing activities. Enter patient data entry into the Clinical Research Management System (CRMS), in order to document all patient enrollment, screen failures, protocol and unscheduled visits, protocol deviations, and Serious Adverse Events. Review all monitoring and auditing reports from Sponsors or granting agencies for all assigned studies, for a completeness, accuracy, discrepancy or protocol deviations. Assis the study team with response to any discrepancies or delinquencies noted in the reports with the Sponsor or granting agencies, as well as to develop a corrective plan of action, if necessary. 15% Clinical Trial Administrative Support Maintain confidential filing system for research files, study participant files, and other correspondence. Assist with labeling, faxing, photocopying, filing, as needed. Handle correspondence and communications as appropriate; compose Memos to Files (MTF), letters or memos of response, telephone triage, when necessary. Assist in obtaining signatures from physicians, clinic and research staff. Participate in weekly disease specific meetings and update investigators and staff on patients and study specifics Assist in quality control and quality assurance activities, including participation in internal QA audits and Sponsor/FDA audits as required. Act as liaison between study sponsors, regulatory agencies, fund management, hospital and clinic departments, as needed. Assist with campus and/or building tours for research related activities. 10% General Responsibilities and Special Projects Provide cross coverage for vacation and sick time for team members, as required. Work flexible hours and/or overtime to meet study deadlines and requirements, when required. Attend all CRU, research and staff meetings, as required. Ensure all training (e.g. Client, HIPAA, GCP, IATA, INFORM, Rave, etc.) is up-to-date and current. Travel to different research locations, as necessitated by the protocol or regulations. Use mouse to move to next section. Use tab key within section. SKILLS, KNOWLEDGE AND ABILITIES TASK REFERENCE IMPORTANCE Bachelor degree in chemistry, biology, nursing or other related field. Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read entries in patient charts, and record accurate and timely information into study records and other appropriate research data forms. All All Required Preferred Clinical research experience, with in-depth knowledge of clinical oncology as it pertains to clinical trials. All Preferred Working knowledge of Good Clinical Practices, as defined by the FDA. All Required Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner. All Required Demonstrated understanding of confidential information (Protected Health Information). All Required Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner. All Required Computer skills using PC platform computers with proficiency. All Required Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax, and punctuation. All Required Demonstrated experience working with Electronic Medical Record (EMR) systems such as Epic, Cerner, etc. Ability to work in a fast-paced environment and to shift priorities to meet deadlines. Skills in performing duties with frequent interruptions and/or distractions. Willingness to travel between Westwood and Santa Monica Clinic. Ability to work with a high level of accuracy especially when preparing lab specimens for shipment and/or delivery to clinical research laboratories. Ability to lift/push/pull up equipment up to approximately 30 lbs. All All All All All All Preferred Required Required Required Required Required
Associated topics: antibody, aseptic technique, biomedical, dietician, disease, drug development, histologist, industrial hygienist, medicine, nutrition