Clinical Research Coordinator II - Department of Medicine
Los Angeles, California
Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.
- Full-time & Per-Diem
- Level: Mid to Senior
- Travel: Minimal (if any)
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What makes a successful Clinical Research Coordinator II - Department of Medicine at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.
Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.
ResponsibilitiesRequisition # HRC0530103B
Grow your career at Cedars-Sinai!
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.
- 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
Our compensation philosophy
We offer competitive total compensation that includes pay, benefits, and other recognition programs for our employees. The base pay range shown above takes into account the wide range of factors that are considered in making compensation decisions including knowledge/skills; relevant experience and training; education/certifications/licensure; and other business and organizational factors. This base pay range does not include our comprehensive benefits package and any incentive payments that may be applicable to this role. Cedars - Sinai's EEO and AA Policy Statement
Diversity and Inclusion at Cedars-Sinai
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve – because that’s what our patients, colleagues and communities deserve. Quality Care and Research—For All, By All.
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Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy. Cedars - Sinai's EEO and AA Policy Statement
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