Clinical Research Coordinator II - Medicine/Endocrinology (Diabetes Program)

Job DescriptionGrow 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.#JobsPrimary 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.

QualificationsRequired Qualifications:

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.

About 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 : HRC0530103CWorking Title : Clinical Research Coordinator II - Medicine/Endocrinology (Diabetes Program)Department : Research - EndocrinologyBusiness Entity : Cedars-Sinai Medical CenterJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : EXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $64,500.00 - $100,000.00Cedars-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.