Clinical Research Specialist jobs at Cedars-Sinai

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. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements! The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only. Primary Duties & Responsibilities: • 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. • Assists with 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 Food and Drug Administration (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. • Participates in required training and education programs Educational Requirements: High School Diploma/GED Bachelors degree in science or related degree preferred Experience: 1-year clinical research related experience preferred Physical Demands: Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. Understanding of general clinical research objectives. Clinical research experience, preferred

**NATIONAL LEADERS IN PEDIATRIC CARE** Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. **It's Work That Matters.** **Overview** **Schedule:** Mon - Fri: 9:00am - 5:00pm **Purpose Statement/Position Summary:** The Clinical Research Coordinator I assists principal investigators or other study team members with research studies and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. **Minimum Qualifications/Work Experience:** 1+ year experience in clinical trial coordination or computerized databases. **Education/Licensure/Certifications:** High School Diploma required. Bachelor's degree or Associate degree in related scientific field preferred. Certified clinical research associate/coordinator preferred. **Pay Scale Information** $61,152.00-$100,464.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Neurology

NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview Schedule: Mon - Fri: 9:00am - 5:00pm Purpose Statement/Position Summary: The Clinical Research Coordinator I assists principal investigators or other study team members with research studies and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Minimum Qualifications/Work Experience: 1+ year experience in clinical trial coordination or computerized databases. Education/Licensure/Certifications: High School Diploma required. Bachelor's degree or Associate degree in related scientific field preferred. Certified clinical research associate/coordinator preferred. Pay Scale Information $61,152.00-$100,464.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Neurology

**NATIONAL LEADERS IN PEDIATRIC CARE** Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. **It's Work That Matters.** **Overview** **Schedule:** Monday-Friday **Purpose Statement/Position Summary:** As a certified research professional, handles clinical trial administration for all protocol phases. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department. Trains new staff. Develops procedures related to clinical trial coordination. In addition, this role supports complex clinical trials involving Bone Marrow Transplant (BMT), CAR-T cell therapy, and stem cell therapies, which require specialized coordination and regulatory oversight. Responsibilities include managing investigational product logistics, monitoring patient safety and adverse events, and ensuring compliance with FDA and institutional protocols. The Clinical Research Coordinator III collaborates closely with transplant physicians, cellular therapy teams, and external sponsors to facilitate high-impact research aimed at improving outcomes for pediatric patients with hematologic malignancies and other life-threatening conditions. **Minimum Qualifications/Work Experience:** 5+ year experience in clinical trial coordination with 2+ years pediatric clinical trials experience. **Preferred Experience:** + In-depth knowledge of BMT clinical workflows, including donor matching, conditioning regimens, engraftment monitoring, and post-transplant complications. + Experience with pediatric BMT populations and familiarity with transplant-related adverse event reporting. + Proficiency in managing regulatory documentation for BMT trials, including IND submissions and FDA correspondence. **Education/Licensure/Certification:** Bachelor's degree or Associate degree in related scientific field. ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP) required. *Candidates with a medical degree are exempt from certification requirement. **Pay Scale Information** $75,712.00-$129,792.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Clinical Research Office Staff

NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview Schedule: Monday-Friday Purpose Statement/Position Summary: As a certified research professional, handles clinical trial administration for all protocol phases. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department. Trains new staff. Develops procedures related to clinical trial coordination. In addition, this role supports complex clinical trials involving Bone Marrow Transplant (BMT), CAR-T cell therapy, and stem cell therapies, which require specialized coordination and regulatory oversight. Responsibilities include managing investigational product logistics, monitoring patient safety and adverse events, and ensuring compliance with FDA and institutional protocols. The Clinical Research Coordinator III collaborates closely with transplant physicians, cellular therapy teams, and external sponsors to facilitate high-impact research aimed at improving outcomes for pediatric patients with hematologic malignancies and other life-threatening conditions. Minimum Qualifications/Work Experience: 5+ year experience in clinical trial coordination with 2+ years pediatric clinical trials experience. Preferred Experience: * In-depth knowledge of BMT clinical workflows, including donor matching, conditioning regimens, engraftment monitoring, and post-transplant complications. * Experience with pediatric BMT populations and familiarity with transplant-related adverse event reporting. * Proficiency in managing regulatory documentation for BMT trials, including IND submissions and FDA correspondence. Education/Licensure/Certification: Bachelor's degree or Associate degree in related scientific field. ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP) required. *Candidates with a medical degree are exempt from certification requirement. Pay Scale Information $75,712.00-$129,792.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Clinical Research Office Staff

Join us as we translate today's discoveries, into tomorrow's medicine! Regenerative medicine is a new and developing field that strives to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases, and we're extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai Are you ready to be a part of breakthrough research? The Clinical Research Associate I will work 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 assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Additionally, this position will include animal work (injections, dissections, and surgery), sample processing, and cell culture. Primary Job Duties and Responsibilities: 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. Assists with patient research billing. Schedules patients 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) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Department-Specific Duties and Responsibilities: Performs data searches and other related administrative tasks. Assists with research protocol writing and development. Transportation of research medications. Performs study related assessments and questionnaires. Assists with prescreening of potential research participants for various clinical trials. 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. Attends research meetings and monthly conference calls with sponsors for study updates. Performs cell culture, immunohistochemistry including processing of samples. Performs animal injections, dissections and surgery. Assists with scheduling of visits and assessments. Education: High School Diploma or GED is required. Experience and Skills: Clinical Research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to follow regulations. Must possess digital literacy, including Word and Excel, and the ability to use standard office equipment is required.

Come join our team! The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. May serve independently as study coordinator for minimal number of noncomplex research studies or projects. What are the Primary Duties & Responsibilities? Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies. Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Completes Case Report Forms (CRFs). Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently. Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines. Assists with clinical trial budgets and patient billing. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities. Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives. Participates in centralized activities such as auditing, Standard Operating Procedure development, etc. May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives. Education, Experience & License/Certification Requirements: High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred. One (1) year of clinical research related experience required Certification in Clinical Research (SOCRA or ACRP) preferred

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 I, you will work under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, pre-screening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Primary Job Duties and Responsibilities: Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Completes Case Report Forms (CRFs). Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. Assists supervising staff 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. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Department-Specific Duties: Maintains CITI certification. Compiles, analyzes, and presents work at internal meetings and conferences. Performs data searches and other related administrative tasks. Assists with research protocol writing and development. Assists with prescreening of research participants for various clinical trials. Attends research meetings and monthly conference calls with sponsors. Maintains organized paper and electronic research files. Performs all data collection and data entry tasks for departmental clinical studies. Assists with preparing manuscripts, letters, and other research documents as needed. Coordinates study related activities and subject recruitment with Laboratory Staff. Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or related degree is preferred. Experience: One year of clinical research related experience is preferred.

The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance. Primary Duties & Responsibilities: 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 the sponsors provide. 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. Assists with patient research billing. Assists with prescreening of potential research participants for various clinical trials. 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 Food and Drug Administration (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. Participates in required training and education programs. Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred. Experience and Skills: No experience required. One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

Key Job Responsibilities The Clinical Research Associate I 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 assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. 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 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. • Assists with 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 Food and Drug Administration (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. • Participates in required training and education programs Qualifications Educational Requirements: - Highschool Diploma Required - Bachelor's Degree Preferred Licenses: N/A Experience: 1 year clinical research experience preferred Physical Demands: - Able to perform moderate lifting. - Able to sit, stand and walk for prolonged periods of time. - Able to read papers and online documents. - Able to operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Are you ready to be a part of breakthrough research? The Clinical Research Associate I 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 assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties & Responsibilities: 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 the sponsors provide. 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. Assists with 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 Food and Drug Administration (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. Participates in required training and education programs. Qualifications Education: High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or a related field. Experience and Skills: One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

Grow your career at Cedars-Sinai! The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography. In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance. Primary Duties & Responsibilities: 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 the sponsors provide. 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. Assists with patient research billing. Assists with prescreening of potential research participants for various clinical trials. 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 Food and Drug Administration (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. Participates in required training and education programs. Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred. Experience and Skills: No experience required. One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

This is a per diem position, offering flexibility to work anywhere from 0 to 40 hours per week, depending on the needs of the department. Scheduling will be determined by the hiring manager based on operational priorities. Please note that per diem team members are not eligible for health benefits, but this role provides an excellent opportunity to gain valuable experience, contribute to meaningful work, and enjoy a flexible schedule. Spanish fluency required: This role requires expert-level fluency in Spanish, including the ability to read, write, and speak, as you will be working closely with a Spanish-speaking population. Outreach travel: The position includes occasional day trips to Bakersfield for outreach activities with the team. Transportation: While having your own vehicle is a plus, it is not required-transportation will be provided for outreach travel. The Clinical Research Associate I 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 assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. 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 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. Assists with 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 Food and Drug Administration (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. Participates in required training and education programs. Qualifications Requirements: High School Diploma/GED required. Preferred: Bachelor's Degree preferred. 1 year Clinical research related experience preferred.

Grow your career at Cedars-Sinai! The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Join our team and contribute to groundbreaking research. The Research Associate II works at a high level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for ensuring timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations, where applicable. Primary Duties and Responsibilities: * Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval. * Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process. * Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent. * Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial. * Ensures timely filing of annual renewals and amendment submissions to IRB. * Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines. * Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. * Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB. * May help coordinate and prepare for institutional, pharmaceutical and internal audits. * Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires. * Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities. * Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals. * Participates in weekly research staff meetings. * Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process. * Performs administrative duties in a timely manner as assigned. Qualifications Requirements: * High School Diploma/GED required. Bachelor's degree preferred. * 1 year Clinical research related experience required. #Jobs-Indeed #LI Req ID : 13668 Working Title : Research Associate II - The Angeles Clinic & Research Institute Department : Angeles Research Inst 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 hour Base Pay : $22.35 - $34.64

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. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements! The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only. Primary Duties & Responsibilities: * 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. * Assists with 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 Food and Drug Administration (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. * Participates in required training and education programs Qualifications Educational Requirements: High School Diploma/GED Bachelors degree in science or related degree preferred Experience: 1-year clinical research related experience preferred Physical Demands: Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. Understanding of general clinical research objectives. Clinical research experience, preferred Req ID : 13483 Working Title : Clinical Research Associate I - Urology Department : Urology 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 : $19.50 - $32.86

Grow your career at Cedars-Sinai! The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography. In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance. Primary Duties & Responsibilities: * 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 the sponsors provide. * 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. * Assists with patient research billing. * Assists with prescreening of potential research participants for various clinical trials. * 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 Food and Drug Administration (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. * Participates in required training and education programs. Qualifications Education: * High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred. Experience and Skills: * No experience required. One (1) year of clinical research related experience is preferred. * Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations. * Ability to convey and/or receive written/verbal information to/from various audiences in different formats. Req ID : 13782 Working Title : Clinical Research Associate I - CA Heart Foundation Department : CA Heart Foundation 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 hour Base Pay : $21.29 - $33.00

The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Join our team and use your experience with an organization known nationally for excellence in research! The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Primary Duties and Responsibilities * Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. * Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. * Completes Case Report Forms (CRFs) * Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. * Assists supervising staff 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 * Responsible for sample preparation and shipping and maintenance of study supplies and kits. * Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (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 serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Qualifications Educational Requirements: * High school diploma/GED required * Bachelor's degree in Science, Sociology or related degree preferred Licenses: * CPT- Phlebotomy Certification license required Experience: 1 year clinical research experience preferred Physical Demands: * Able to perform moderate lifting. * Able to sit, stand and walk for prolonged periods of time. * Able to read papers and online documents. * Able to operate standard office equipment. * Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. Req ID : 9809 Working Title : Heart Institute Clinical Research Assoc I/CPT, Dr. Cheng Lab Department : Heart Institute 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 : $19.50 - $32.86

The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. **Join our team and use your experience with an organization known nationally for excellence in research!** The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. **Primary Duties and Responsibilities** + Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. + Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. + Completes Case Report Forms (CRFs) + Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. + Assists supervising staff 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 + Responsible for sample preparation and shipping and maintenance of study supplies and kits. + Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (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 serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. **Qualifications** **Educational Requirements:** - High school diploma/GED required - Bachelor's degree in Science, Sociology or related degree preferred **Licenses:** - CPT- Phlebotomy Certification license required **Experience:** 1 year clinical research experience preferred **Physical Demands:** - Able to perform moderate lifting. - Able to sit, stand and walk for prolonged periods of time. - Able to read papers and online documents. - Able to operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. **Req ID** : 9809 **Working Title** : Heart Institute Clinical Research Assoc I/CPT, Dr. Cheng Lab **Department** : Heart Institute **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** : $19.50 - $32.86 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.

Grow your career at Cedars-Sinai! The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Join our team and use your skills with an organization known nationally for excellence in research! Job Responsibilities 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 assist with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research 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 study. • Evaluates and abstracts clinical research data from source documents. • Completes Case Report Forms (CRFs). • Enters clinical research data into Electronic Data Systems (EDCs) that are 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 Institutional Review Board 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 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 Food and Drug Administration (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. • Participates in required training and education programs. 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, Standard Operating Procedure development, etc. • May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications Qualifications Educational Requirements: - Highschool diploma required - Bachelor's degree preferred Licenses:- SOCRA or ACRP certification preferred Experience: - 1 year clinical research related experience required Physical Demands: - Able to perform moderate lifting. - Able to sit, stand and walk for prolonged periods of time. - Able to read papers and online documents. - Able to operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.