Clinical Research Coordinator II – Biobank Research Program – Department of Neur
Cedars-Sinai, Los Angeles, CA, United States
Overview
Clinical Research Coordinator I
will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meetings. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
About the Team
Ongoing advances in science and technology make it possible to explore the causes of disease at the genetic level. The Cedars-Sinai Biobank is a place where biological samples, such as tissue, blood and urine, are stored along with selecting health information for later use in biomedical research. Researchers use the Biobank like a library, accessing samples with diverse genetic characteristics to explore answers to scientific questions.
About the Role
The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I member is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meetings. This position ensures compliance with all federal and local agencies including the FDA and local IRB.
Primary Duties and Responsibilities
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
Schedules and participates in monitoring and auditing activities.
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 following local and federal guidelines.
May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Coordinates training and education of other personnel.
Department-Specific Duties and Responsibilities
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors for study updates.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.
Qualifications
Education
High School Diploma/GED, required.
Bachelor’s degree in a Science, Sociology, or related field, preferred.
Licenses/Certifications
ACRP/SOCRA certification is preferred.
Experience
2 years of clinical research related experience is 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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Clinical Research Coordinator I
will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meetings. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
About the Team
Ongoing advances in science and technology make it possible to explore the causes of disease at the genetic level. The Cedars-Sinai Biobank is a place where biological samples, such as tissue, blood and urine, are stored along with selecting health information for later use in biomedical research. Researchers use the Biobank like a library, accessing samples with diverse genetic characteristics to explore answers to scientific questions.
About the Role
The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I member is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meetings. This position ensures compliance with all federal and local agencies including the FDA and local IRB.
Primary Duties and Responsibilities
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
Schedules and participates in monitoring and auditing activities.
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 following local and federal guidelines.
May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Coordinates training and education of other personnel.
Department-Specific Duties and Responsibilities
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors for study updates.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.
Qualifications
Education
High School Diploma/GED, required.
Bachelor’s degree in a Science, Sociology, or related field, preferred.
Licenses/Certifications
ACRP/SOCRA certification is preferred.
Experience
2 years of clinical research related experience is 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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