Job DescriptionJoin Cedars-Sinai and become part of a team that is at the forefront of medical advancements!The Division of Rheumatology at Cedars-Sinai has established a comprehensive clinical and translational research program. This involves a streamlined infrastructure (Translational Research Unit or TRU) to support prospective cohorts of patients affected by rheumatic diseases such as scleroderma, systemic lupus erythematosus and rheumatoid arthritis, as well as participation in ground breaking clinical trials.Dr. Francesco Boin is a physician-scientist with extensive experience in the diagnosis and treatment of scleroderma and other fibrosing skin disorders. His research is focused on the genetic risk of scleroderma and the biology of immune cells involved in the pathogenesis of this disease.We are seeking a Clinical Research Coordinator I to participate in all the clinical and translational research activities of the Scleroderma Program and the Division of Rheumatology. To learn more, please visit: https://www.cedars-sinai.org/programs/rheumatology.html. The incumbent will work closely with Scleroderma Program and Rheumatology faculty investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting.Primary Duties and Responsibilities:
Independent study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
May identify new research opportunities and presents to investigators.
QualificationsEducation:
High School Diploma/GED is required.
Bachelor's degree in a Science, Sociology, or related field is preferred.
Licenses/Certifications:
ACRP/SoCRA certification is preferred.
Experience:
One (1) year of clinical research experience, required.
#Jobs-IndeedAbout UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.About the TeamCedars-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. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.Req ID : 4968Working Title : Clinical Research Coordinator I – Translational Research Unit – RheumatologyDepartment : Research - RheumatologyBusiness Entity : Cedars-Sinai Medical CenterJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : NONEXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $23.39 - $39.76Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.
