Cedars-Sinai
Clinical Research Associate II - Cardiology - Towers
Cedars-Sinai, Los Angeles, California, United States, 90079
Job Description
The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for the study and assists with study budget and patient research participant billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties and Responsibilities Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement the study. Evaluates and abstracts clinical research data from source documents. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) provided by the sponsors. 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 works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Schedules research participants for research visits and procedures. Responsible for sample preparation, shipping, and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the FDA and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines and strict patient confidentiality according to HIPAA regulations. Participates in required training and education programs and may be involved in training and education of other Clinical Research Associates. Serves as the point of contact for external sponsors for select trials. Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives. Participates in centralized activities such as auditing and Standard Operating Procedure development. May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications.
Qualifications
High school diploma required Bachelor's degree preferred SOCRA or ACRP certification preferred 1 year clinical research related experience required
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
With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai’s medical network serves people near where they live. Delivering coordinated, compassionate healthcare, you can join our network of clinicians and physicians to improve healthcare for people throughout Los Angeles and beyond. Req ID : 3384 Working Title : Clinical Research Associate II - Cardiology - Towers Department : Cardiology - Towers Business Entity : Cedars-Sinai Medical Care Foundation Job Category : Academic / Research Job Specialty : Research Studies/Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hours Base Pay : $23.93 - $35.90 #J-18808-Ljbffr
The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for the study and assists with study budget and patient research participant billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties and Responsibilities Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement the study. Evaluates and abstracts clinical research data from source documents. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) provided by the sponsors. 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 works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Schedules research participants for research visits and procedures. Responsible for sample preparation, shipping, and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the FDA and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines and strict patient confidentiality according to HIPAA regulations. Participates in required training and education programs and may be involved in training and education of other Clinical Research Associates. Serves as the point of contact for external sponsors for select trials. Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives. Participates in centralized activities such as auditing and Standard Operating Procedure development. May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications.
Qualifications
High school diploma required Bachelor's degree preferred SOCRA or ACRP certification preferred 1 year clinical research related experience required
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
With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai’s medical network serves people near where they live. Delivering coordinated, compassionate healthcare, you can join our network of clinicians and physicians to improve healthcare for people throughout Los Angeles and beyond. Req ID : 3384 Working Title : Clinical Research Associate II - Cardiology - Towers Department : Cardiology - Towers Business Entity : Cedars-Sinai Medical Care Foundation Job Category : Academic / Research Job Specialty : Research Studies/Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hours Base Pay : $23.93 - $35.90 #J-18808-Ljbffr