The Division of Rheumatology at Cedars-Sinai has established a comprehensive clinical and translational research program. We are involved in a streamlined infrastructure to support prospective cohorts of patients affected by rheumatic diseases (i.e. disease-based centers of excellence revolving around conditions such as scleroderma, systemic lupus erythematosus, rheumatoid arthritis) and participation in cutting-edge clinical trials.
The CRC II will work closely with Scleroderma Center investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting.
Job Duties and Responsibilities:
Independent study coordination including screening of potential 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 regular 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. Coordinates training and education of other personnel.
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 present to investigators.
Participates in required training and education programs.
Department Specific Job Responsibilities:
Attend weekly meetings and other meetings as needed with the director and division members.
Assist Scleroderma Center investigators with IRB document preparation and protocol development by developing SOPs for all Scleroderma Center research activities, generating and maintaining inventory of materials used for research, assuring compliance with approved study protocols, creating or modifying data collection forms.
Develop 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
Streamline 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
Recruit and consent 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.
Attend weekly meetings and other meetings as needed with the director and division members
Assist Scleroderma Center investigators in setting up and conduct clinical trials, developing, implementing, and coordinating research and administrative procedures for the successful management of clinical trials.
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
Discuss study protocols with patients and verify the informed consent documentation.
Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study.
Dispense study medication in a professional and accountable manner following protocol requirements.
Collect, process, and ship blood/urine specimens at scheduled patient visits.
Schedule all patient research visits and procedures consistent with protocol requirements.
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy.
Administer questionnaires/diaries per protocol.
Ensure that non-serious and serious adverse events are properly documented and reported.
Screen all laboratory results when received and follow protocol procedure regarding abnormal results.
Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder.
Ensure the filing and maintenance of all regulatory documents.
Schedule monitor visits and set up for monitoring visits prior to monitor's arrival.
Bachelor of Arts or Sciences degree, required
Four (4) years minimum of directly related experience required
Experience using database software (i.e. MS Access, REDCap, etc.), preferred.
Experience with electronic medical records and/or medical applications (i.e. CS-Link/EPIC), preferred.
Fluency in spreadsheet software; ability to develop complex spreadsheets independently and integrate data from medical applications and other sources to compile information, queries and reports, preferred.
In-depth knowledge of clinical research contracts and grants, clinical research methodology, protocols, FDA regulations, and complex visit structures, preferred.
Previous related experience in clinical research setting, preferred.
Knowledge of medical and rheumatology terminology; experience and knowledge of IRB policy and procedure, preferred.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.