Cedars-Sinai Clinical Research Coordinator II - Cancer Clinical Trials Office in Los Angeles, California
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Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.
Are you looking to contribute to groundbreaking research? We look forward to having you come and join our team!
The Clinical Research Coordinator II works independently providing study coordination support for prospective epidemiologic studies and clinical trials. Responsibilities may include screening of prospective participants for protocol eligibility, presenting an overview of study motivation and procedures, participating in the informed consent process, administering questionnaires, scheduling and follow-up of research study participants, transporting biospecimens from procedure rooms to the processing laboratory.
Essential Job Duties and Responsibilities:
Independent study coordination including screening of prospective patients for protocol eligibility, presenting non-medical trial concepts and details to the patients.
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents detailed 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 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 / IRB 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 IRB).
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for growing patient enrollment, and/or improving clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required education programs.
Department and/or Unit Specific – Essential 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, CRFs, manual of operations, and tracking forms for studies.
Establishes data collection process for studies and standardize data collection, including data flow, data management, data entry, error identification and correction.
Work closely with Principal Investigator (PI) to organize 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) ,if applicable, according to Cedars-Sinai policies.
Coordinates/implements patient specimen collection for research purposes.
Trains and communicates with coordinators at other institutions for protocol implementation.
- BA/BS degree.
- ACRP/SoCRA (or equivalent) certification preferred.
Four years of directly related experience, required.
Five or more years of clinical research experience, 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.