Cedars-Sinai
Clinical Research Coordinator II, Thoracic (Hybrid) at Cedars-Sinai Beverly Hill
Cedars-Sinai, Beverly Hills, California, United States, 90211
Job Description
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and participating in the informed consent process.
Schedules patients for research visits and procedures. Documents thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and 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; compiles and reports on each study including protocol activity, accrual data, and workload; presents this information at regular research staff meetings.
Notifies direct supervisor of 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 perform other regulatory or Institutional Review Board duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the 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 coordinate training and education of other personnel.
May participate in centralized activities such as auditing, SOP development, etc.
May plan and coordinate strategies for increasing patient enrollment and/or improving clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in developing action plans to improve quality.
May identify new research opportunities and present them to investigators.
Participates in required training and education programs.
Qualifications
High School Diploma/GED required. Bachelor’s Degree in Science, Sociology, or related field preferred.
2 years clinical research related experience required.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of 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.
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The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and participating in the informed consent process.
Schedules patients for research visits and procedures. Documents thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and 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; compiles and reports on each study including protocol activity, accrual data, and workload; presents this information at regular research staff meetings.
Notifies direct supervisor of 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 perform other regulatory or Institutional Review Board duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the 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 coordinate training and education of other personnel.
May participate in centralized activities such as auditing, SOP development, etc.
May plan and coordinate strategies for increasing patient enrollment and/or improving clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in developing action plans to improve quality.
May identify new research opportunities and present them to investigators.
Participates in required training and education programs.
Qualifications
High School Diploma/GED required. Bachelor’s Degree in Science, Sociology, or related field preferred.
2 years clinical research related experience required.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of 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.
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