Cedars-Sinai
Clinical Research Associate I - Heart Institute
Cedars-Sinai, Los Angeles, California, United States, 90079
Overview
Clinical Research Associate I - Heart Institute at Cedars-Sinai. The role works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. 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 as needed for study and assists with study budgets and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Provides primary support to the Research Director on academic activities. Responsibilities
Provides primary support to the Research Director on his academic activities (seminars, lectures, meetings, writing, and editorial commitments). May include preparing first drafts, editing drafts, and submitting materials on his behalf. Provides other general administrative support to the Research Director, as needed. Works directly with imaging technicians, ancillary support team, investigators, nurses, nurse practitioners, and/or biostatisticians to perform clinical research studies. Designs forms for data collection/abstraction. Performs data collection/abstraction. Retrieves non-controlled substance medication from and returns unused medication to pharmacy when medication is needed for administration to a patient by a clinic staff member. Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Provides supervised patient contact or patient contact for long-term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets and patient research billing. Schedules patients for research visits and research procedures. Responsible for sample preparation and 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. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications
High School Diploma/GED required Bachelor's Degree in Science, Sociology or related degree preferred 1 year clinical research related experience preferred
#J-18808-Ljbffr
Clinical Research Associate I - Heart Institute at Cedars-Sinai. The role works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. 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 as needed for study and assists with study budgets and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Provides primary support to the Research Director on academic activities. Responsibilities
Provides primary support to the Research Director on his academic activities (seminars, lectures, meetings, writing, and editorial commitments). May include preparing first drafts, editing drafts, and submitting materials on his behalf. Provides other general administrative support to the Research Director, as needed. Works directly with imaging technicians, ancillary support team, investigators, nurses, nurse practitioners, and/or biostatisticians to perform clinical research studies. Designs forms for data collection/abstraction. Performs data collection/abstraction. Retrieves non-controlled substance medication from and returns unused medication to pharmacy when medication is needed for administration to a patient by a clinic staff member. Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Provides supervised patient contact or patient contact for long-term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets and patient research billing. Schedules patients for research visits and research procedures. Responsible for sample preparation and 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. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications
High School Diploma/GED required Bachelor's Degree in Science, Sociology or related degree preferred 1 year clinical research related experience preferred
#J-18808-Ljbffr