Job Description

　　Join 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.

　　Department-Specific Responsibilities:

　　Participates in weekly meetings and other meetings as needed with the director, research program manager and/or division members.

　　Assists division investigators and research program manager with IRB document preparation and protocol development by developing SOPs for all research activities, generating and maintaining inventory of materials used for research, assuring compliance with approved study protocols, creating or modifying data collection forms.

　　Develops and maintain study databases, responsible for data entry and data quality/integrity, producing on-demand reports, optimizing data collection workflows and tracking data/sample requests and transfers.

　　Streamlines data/bio specimen collection sharing, ensuring integrity and security of incoming and stored samples, arranging the exchange of and transport of specimens with collaborating Investigators and staff, overseeing the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.

　　Recruits and consents study participants, tracking recruitment efforts for IRB and internal reporting, collecting processing, and storing tissue samples, assisting with research procedures such as phlebotomy and skin biopsies.

　　Assists Scleroderma Program/Division investigators and research program manager in setting up and conduct clinical trials, developing, implementing, and coordinating research and administrative procedures for the successful management of clinical trials.

　　Ensures scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.

　　Reviews study protocols with patients and verify the informed consent documentation.

　　Meets with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study.

　　Dispenses study medication in a professional and accountable manner following protocol requirements.

　　Collects, processes, and ships blood/urine specimens at scheduled patient visits.

　　Schedules all patient research visits and procedures consistent with protocol requirements.

　　Completes and maintains case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy.

　　Administers questionnaires/diaries per protocol.

　　Ensures that non-serious and serious adverse events are properly documented and reported.

　　Screens all laboratory results when received and follow protocol procedure regarding abnormal results.

　　Ensures all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder.

　　Ensures the filing and maintenance of all regulatory documents.

　　Schedules monitor visits and sets up for monitoring visits prior to monitor’s arrival.

　　Assists with projects related to the division within the Translational Research Unit, as needed.

　　Qualifications

　　Education:

　　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.

　　Physical Demands:

　　Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

　　About Us

　　Cedars-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 Team

　　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. 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 : HRC1450729

　　Working Title : Clinical Research Coordinator I - Translational Research Unit - Rheumatology

　　Department : Research - Rheumatology

　　Business Entity : Cedars-Sinai Medical Center

　　Job Category : Academic / Research

　　Job Specialty : Research Studies/ Clin Trial

　　Overtime Status : NONEXEMPT

　　Primary Shift : Day

　　Shift Duration : 8 hour

　　Base Pay : $23.39 - $39.76

　　Cedars-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.