Clinical Research Associate II - Division of Endocrinology, Diabetes, and Metabolism / Department of Medicine - Cedars-Sinai
Los Angeles, CA
About the Job
Job Description
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
As a Clinical Research Associate II, you will work directly with a Principal Investigator, Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs) and entering clinical research data, and assist with regulatory submissions to the IRB. The CRA II provides limited patient contact with research participants as needed for study and assists with study budget and patient research participant research billing. In addition, the incumbent will coordinate activities (meetings, conference calls, travel, etc.), training, and education for other internal and external research team members. This role will follow all federal, local, FDA, IRB, IACUC, and HIPAA guidelines and regulations pertaining to the study, animal welfare, and patient care.
Primary Job Duties and Responsibilities:
+ Enters clinical and basic research data into internal or external database systems provided.
+ Provides supervised contact with research participants or contact for long term follow-up research participants only.
+ Assists with regulatory submissions to the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) and works closely with supervising research staff or directly with the IRB or IACUS (as appropriate) to submit Adverse Events, Serious Adverse Events, Safety Letters in accordance, or animal welfare concerns in accordance with local and federal guidelines.
+ Assists with clinical trial and basic research budget preparation. Assists with patient research billing.
+ Schedules research participants for research visits and research procedures.
+ Responsible for sample preparation and shipping and maintenance of study supplies and kits.
+ Maintains research practices using Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines.
+ Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
+ Participates in required training and education programs.
+ May participate in the development of Investigator initiated trials for Investigational New Drug applications and/or Device applications.
+ May be involved in training and education of other Clinical Research Associates.
+ Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Qualifications
Education:
+ High School Diploma/GED, required.
+ Bachelor's degree in Science, Sociology, or related degree, preferred.
Licenses/Certifications:
+ ACRP/SOCRA certification is preferred.
Experience and Skills:
+ 1 year of clinical research experience is required.
+ Must have strong MS Office digital literacy, conduct Internet searches, and ability to become proficient using related organizational and sponsor software programs.
Physical Demands:
About Us
Cedars-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 Team
Cedars-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 : 5409
Working Title : Clinical Research Associate II - Division of Endocrinology, Diabetes, and Metabolism / Department of Medicine
Department : Research - Endocrinology
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $23.00 - $36.14
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.
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
We invite you to consider this phenomenal opportunity!
As a Clinical Research Associate II, you will work directly with a Principal Investigator, Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs) and entering clinical research data, and assist with regulatory submissions to the IRB. The CRA II provides limited patient contact with research participants as needed for study and assists with study budget and patient research participant research billing. In addition, the incumbent will coordinate activities (meetings, conference calls, travel, etc.), training, and education for other internal and external research team members. This role will follow all federal, local, FDA, IRB, IACUC, and HIPAA guidelines and regulations pertaining to the study, animal welfare, and patient care.
Primary Job Duties and Responsibilities:
+ Enters clinical and basic research data into internal or external database systems provided.
+ Provides supervised contact with research participants or contact for long term follow-up research participants only.
+ Assists with regulatory submissions to the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) and works closely with supervising research staff or directly with the IRB or IACUS (as appropriate) to submit Adverse Events, Serious Adverse Events, Safety Letters in accordance, or animal welfare concerns in accordance with local and federal guidelines.
+ Assists with clinical trial and basic research budget preparation. Assists with patient research billing.
+ Schedules research participants for research visits and research procedures.
+ Responsible for sample preparation and shipping and maintenance of study supplies and kits.
+ Maintains research practices using Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines.
+ Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
+ Participates in required training and education programs.
+ May participate in the development of Investigator initiated trials for Investigational New Drug applications and/or Device applications.
+ May be involved in training and education of other Clinical Research Associates.
+ Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Qualifications
Education:
+ High School Diploma/GED, required.
+ Bachelor's degree in Science, Sociology, or related degree, preferred.
Licenses/Certifications:
+ ACRP/SOCRA certification is preferred.
Experience and Skills:
+ 1 year of clinical research experience is required.
+ Must have strong MS Office digital literacy, conduct Internet searches, and ability to become proficient using related organizational and sponsor software programs.
Physical Demands:
About Us
Cedars-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 Team
Cedars-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 : 5409
Working Title : Clinical Research Associate II - Division of Endocrinology, Diabetes, and Metabolism / Department of Medicine
Department : Research - Endocrinology
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $23.00 - $36.14
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.
Source : Cedars-Sinai
