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Cedars-Sinai offers a culture of happiness, passion, and dedication.
Dr. Mark Goodarzi, MD, PhD is seeking a Clinical Research Coordinator II to join a dynamic team.
Dr. Goodarzi leads the Microbiome and Insulin Longitudinal Evaluation Study, which is the first prospective study examining the effects of the gut microbiome and diet on insulin resistance, insulin sensitivity and insulin clearance, to establish the causal role of gut microbes in the development of diabetes.
A complex relationship exists between diabetes and pancreatitis. Diabetes has been long recognized as a risk factor for pancreatitis. Recent research has now documented the reverse relationship: that pancreatitis, even a single uncomplicated episode, may increase the risk of future development of diabetes. Cedars-Sinai is participating in a national multi-center study to better understand the incidence and characteristics of diabetes occurring after pancreatitis. This position will support coordination of this study, as well as related protocols examining the relationships between diabetes, acute pancreatitis, chronic pancreatitis, and pancreatic cancer.
Do you have a passion for helping human kind?
The Clinical Research Coordinator II works independently providing study coordination support for prospective epidemiologic studies and clinical trials. Responsibilities may include administering questionnaires, scheduling and follow-up of research study participants, transporting bio-specimens from procedure rooms to the processing laboratory. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities.
Primary Duties and Responsibilities:
- Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Scheduling of patients 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 patient 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 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 patient research 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 patient confidentiality according to HIPAA regulations and applicable law.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- Participates in required training and education programs.
Department-Specific Job Responsibilities:
- Conducts literature reviews and assists in the design of investigator-initiated studies including protocol design and development.
- Works with PI to design and develop study related documents including questionnaires, Case Report Forms, manual of operations, and tracking forms for assigned studies.
- Establishes data collection process for assigned studies and standardize data collection, including data flow, data management, data entry, error identification and correction.
- Work closely with Principal Investigator (PI) to streamline research study implementation, enrollment, and tracking of study conduct and progress for assigned studies.
- May be trained on study related machine/equipment and procedures by either study sponsor, PI, or PI designee, if necessary, for research study.
- May conduct non-invasive clinical assessments (e.g., vital signs, FibroScan) for research purposes, if applicable, according to Cedars-Sinai policies.
- Coordinates/implements patient specimen collection and handling of specimens.
- Trains and communicates with coordinators at other institutions for protocol implementation.
- Local travel to other sites might be required.
- Flexible work hours during weekends.
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Requirements:
- High School Diploma/GED is required.
- Two (2) years of relevant experience in clinical research is required.
- Bachelor’s degree is preferred.
- ACRP/SoCRA certification is preferred.
- Prior experience in diabetes research preferred.
- Ability to use discretion and maintain privacy, confidentiality or anonymity.
- Ability to interpret and apply knowledge of State, Federal and Agency standards to align with regulations.
- Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Working Title: Clinical Research Coordinator II – Department of Medicine
Department: Home Dept – Endocrinology
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$64,500.00 – $100,000.00