Clinical Research Coord I - Smidt Heart Institute / Barbra Streisand Women's Heart Center (BSWHC) - Bairey Merz Lab

Job Description

As a Clinical Research Coordinator I, 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. You will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Will be responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Essential job duties and responsibilities:

• Independent study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
• Scheduling 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; presents this information at regular research staff meetings.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Independently works with external study monitors and/or auditors.
• 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 in accordance with local and federal guidelines.
• May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
• May supervise Clinical Research Associates on data entry, data query and resolution.
• 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 research participant confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Qualifications

Education required:

• Bachelor of Science/Bachelor of Arts Degree is strongly preferred

LIcense required:

• ACRP/SoCRA (or equivalent) certification preferred

Experience required:

• One (1) year minimum directly related clinical research experience is required.

About Us

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

About the Team

Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.