Cedars-Sinai Clinical Research Coordinator II - Diabetes in Los Angeles, California
Do you have a passion for helping human kind?
The Cancer Prevention and Control Program at Cedars-Sinai conducts multi-disciplinary research projects prioritizing molecular epidemiological approaches to cancer and risk factor prevention, risk assessment, treatment and rehabilitation. A central focus of the Program is to translate laboratory and population health research at Cedars-Sinai Medical Center into clinical interventions that reduce the risk of cancer, slow the progression of cancer, reduce the toxicity of cancer treatment, and enhance the quality of life in our patients. Our team interfaces with a diverse array of research participants, including healthy volunteers, individuals with diabetes, individuals at risk for cancer, individuals with gastrointestinal conditions, and individuals with cancers. This position will support the coordination of study of diabetes and pancreatitis, which are risk factors for cancer.
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 biospecimens 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 for research purposes.
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, required
Bachelor of Science in Sociology or related degree, preferred
Experience and skillset:
Two (2) years of experience in clinical research related required
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 comply with regulations
Ability to convey and/or receive written/verbal information to/from various audiences in different formats
- ACRP/SoCRA (or equivalent) certification preferred
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.