Heart Institute Clinical Research Associate I - Makkar Group

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!

The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Researsh 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. Provides primary support to the Research Director on his academic activities.

• Provides primary support to the Research Director on his academic activities (seminars, lectures, meeting, 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 technician, ancillary support team, Investigators, nurses, nurse practitioners, and/or biostatistician to perform clinical research studies.
• Designs forms for data collection/abstraction. Performs data collection/abstraction.
• Retrieves non-controlled substance medication from and return 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.
• 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.

• High School Diploma/GED required
• Bachelor's Degree in Science, Sociology or related degree preferred