Cedars-Sinai
Clinical Research Coordinator III - Cardiology Research - Makkar Lab
Cedars-Sinai, Los Angeles, California, United States, 90079
Clinical Research Coordinator III - Cardiology Research - Makkar Lab
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.
The Clinical Research Coordinator III works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group, assignment of studies to clinical research personnel, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details to the patients, and participating in the informed consent process.
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, document thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintain accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedule and participate in monitoring and auditing activities.
Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notify direct supervisor about concerns regarding data quality and study conduct.
Work closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintain research practices using Good Clinical Practice (GCP) guidelines.
Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
Work with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Identify new research opportunities and present to investigators.
Supervise other research staff.
Qualifications Education
High School Diploma/GED required.
Bachelor's degree in Science, Sociology, or a related field preferred.
License/Certification
Certification in Clinical Research from ACRP/SOCRA is preferred.
Experience
Four (4) years of clinical research related experience is required.
Req ID: 13090 | Working Title: Clinical Research Coordinator III - Cardiology Research - Makkar Lab | Department: Research - Cardiology | Business Entity: Cedars‑Sinai Medical Center | Job Category: Academic / Research | Job Specialty: Research Studies / Clin Trial | Overtime Status: EXEMPT | Primary Shift: Day | Shift Duration: 8 hour | Base Pay: $34.24 - $58.21
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The Clinical Research Coordinator III works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group, assignment of studies to clinical research personnel, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details to the patients, and participating in the informed consent process.
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, document thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintain accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedule and participate in monitoring and auditing activities.
Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notify direct supervisor about concerns regarding data quality and study conduct.
Work closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintain research practices using Good Clinical Practice (GCP) guidelines.
Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
Work with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Identify new research opportunities and present to investigators.
Supervise other research staff.
Qualifications Education
High School Diploma/GED required.
Bachelor's degree in Science, Sociology, or a related field preferred.
License/Certification
Certification in Clinical Research from ACRP/SOCRA is preferred.
Experience
Four (4) years of clinical research related experience is required.
Req ID: 13090 | Working Title: Clinical Research Coordinator III - Cardiology Research - Makkar Lab | Department: Research - Cardiology | Business Entity: Cedars‑Sinai Medical Center | Job Category: Academic / Research | Job Specialty: Research Studies / Clin Trial | Overtime Status: EXEMPT | Primary Shift: Day | Shift Duration: 8 hour | Base Pay: $34.24 - $58.21
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