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 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 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 skill with an organization known nationally for excellence in research!

Job Summary:

Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.

As a Clinical Research Coordinator III, you will work independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. This position is responsible for the oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. The incumbent plans and coordinates strategies for growing research participant enrollment, improving efficiency, training of personnel, and identifying new research opportunities. The CRC III member ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

• Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.
• Schedules of research participants for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains 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.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at research staff meetings.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.
• May involve other regulatory duties, budgeting duties, and assisting with research participant billing and reconciliation.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.
• Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Offers strategies to improve clinical research efficiency.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans.
• Identifies new research opportunities and presents to investigators.
• Supervises other clinical research staff in day to day operations. Provides input in the performance review of the staff.
• Coordinates and leads routine research meetings.
• Works on both industry sponsor initiated and investigator initiated clinical trials.
• Provides training to junior level coordinators.
• Invoices sponsors and pays clinical trial invoices.
• Prepares and manages clinical trial budgets.
• Supervises other research staff.

Education:

• High School Diploma/GED, required.
• Bachelor's degree, preferred.

Licenses/Certifications:

ACRP/SOCRA (or equivalent) certification, preferred.

Experience:

5 years of clinical research 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.