The Clinical Research Specialist II (Clinical Trial Navigator) provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
Maintain Program Elements: Easy access to information regarding active clinical trials for multiple constituencies; outreach materials at the patient, investigator and public levels; a system to link eligible patients to active clinical trials and the appropriate investigator; support unit for patients who are enrolled in clinical trials; and linkages to CSMC programs and departments.
Fosters the awareness of physicians and staff of available cancer clinical trials, and identifies cancer clinical trials appropriate for cancer cases seen at CSMC.
Educates potential protocol subjects and facilitating patients' participation in appropriate protocols. Ensures dataflow between the Clinical Research Office (CRO) and referring sites, and pursuing community outreach to promote cancer screening activities.
Develops mechanisms for communication with General Surgery, Thoracic Surgery, Internal Medicine, Gastroenterology and other disciplines that treat early stage and at-risk patients who do not generally come to Oncology Clinics to promote patient referrals within CSMC to SOCCI investigators.
May be responsible for the pick-up and delivery of clinical research-related items such as medications
Participates in community outreach measures to educate the public on cancer clinical trials, and enhance awareness of clinical trials at CSMC; engages in outreach to community physicians
Works with the CRO Director and others to support NCI Cancer Center designation preparation including Data Table 3 development
Serves on the Commission on Cancer to represent research efforts Cedars-wide; prepares reports and provide updates on metrics and research efforts
Utilize data to develop processes with Research Center on Health Equity (RCHE) support to engage various SOCCI entities to support improved minority participation. Establish annual recruitment QI goals and processes to improve minority participation by engaging management(i.e. SOCCI clinical staff implements "Ask Me About Clinical Trials" campaign, incorporate as QI mandates in Commission on Cancer efforts. )
Utilize research tested culturally appropriate communications to recruit and navigate minorities to clinical trials with RCHE support. Address institutional and other barriers minority patients have to ensure successful enrollment and retention. Utilize data on patients who decline participation and their reasons to inform future recruitment strategies.
Collaborate with the Research Center on Health Equity to identify and address system-level barriers for minorities, including travelling to off-site locations to enroll interested patients. Maintain an information and communication email address and phone line, and feature up-to-date open trials information on-line.
Collaborate with the RCHE to pilot and implement multi-lingual campaigns to increase minority enrollment system-wide and within the community (i.e. TACRI clinical trials awareness and enrollment pilot) .
Collaborate with the RCHE to conduct community outreach, awareness and enrollment through SOCCI, Cedars-Sinai affiliated providers and community providers.
Partner with Cedars-Sinai Development Division and RCHE to garner foundation and other resources for targeted programs and initiatives within SOCCI, larger community and with providers to increase awareness and minority participation, especially within the Catchment Area and with populations of interest (LGBT, Filipino, Korean, Hispanic Latino, Immigrants).
Utilize appropriate PR and Marketing strategies to promote participation of target communities in trials including featuring new trials in ethnic media and sponsored on-line platforms.
Represent SOCCI in community-based programs and events, which may include speaking at meetings/seminars as well as coordinating and staffing the information table or even organizing an awareness day on campus that includes the community.
Liaison with clinical trial management system administrators to ensure reporting of patients referred and enrolled. Database should track patient outcomes, such as accept and declines for enrollment, reasons for declining if applicable, which trial enrolled, patient sociodemographic data, and clinical outcomes on trial.
Assist with recruitment, screening and enrollment of study participants, which may including the informed consent process. Provide support and financial navigation to ensure successful enrollment.
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards in quality and innovation in patient care, research, teaching and community service. Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients.Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S. with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Clinical programs range from primary care for preventing, diagnosing and treating common conditions to specialized treatments for rare, complex and advanced illnesses. In addition, Cedars-Sinai serves the community through its Medical Network, which includes the highly rated Cedars-Sinai Medical Group and Cedars-Sinai Health Associates. Cedars-Sinai has consistently been named one of America’s Best Hospitals by U.S. News & World Report, has received the National Research Corporation’s Consumer Choice Award 18 years in a row for providing the highest quality medical care in Los Angeles, and has the longest running Magnet desig...nation for nursing excellence in California. Cedars-Sinai is a leader in the clinical care and research of heart disease, cancer and brain disorders, among other areas. Pioneering research achievements include using cardiac stem cells to repair damaged hearts, developing minimally invasive surgical techniques and discovering new types of drugs to target cancer more precisely. Cedars-Sinai also impacts the future of healthcare through education programs that encompass everything from highly competitive medical residency and fellowship programs to a biomedical science and translational medicine PhD program, advanced training for nurses and educational opportunities for allied health professionals. Most notably, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.