Clinical Research Monitoring (CRA)

The mission of the California Heart Center is to integrate quality health care, clinical research, and continuing education to create an environment where advances are fostered for the immediate benefit of patients.
CalHeart, affiliated with the Cedars-Sinai Smidt Heart Institute, offers the full spectrum of cardiology care, including cardiac evaluation, heart failure management, interventional cardiology, nuclear cardiology, echocardiography and hypertension management.
Are you ready to be a part of breakthrough research?
This position functions as a Clinical Research Associate providing support for clinical research protocols. The Clinical Research Associate will assist the Research Department with all aspects of clinical research regulatory. This individual will interact with all clinic and research staff, laboratory staff, medical professionals, and pharmaceutical staff.
Researches reference materials and summarizes research findings.
Current knowledge of GCP guidelines including protection of human subjects and regulations relevant to the performance and conduct of clinical trials
Maintain Regulatory Files for all Clinical Trials
Prepare and submit documents to the IRB which includes initial site submission forms, continuing review reports, initial and revised consents, amendments to the protocol, investigator brochures, protocol deviations, SAE reports, and IND safety reports, close-out reports, patient provided documents, such as QOLs, letters, and diaries.
Prepare and submit to sponsor FDA Form 1572, financial disclosures, CVs and medical licenses
Ensures site is utilizing the current regulatory documents including the informed consent forms, protocols, forms, and investigator brochures
Participates in the weekly research meeting
Maintain site delegation logs for all clinical trials
Act as regulatory liaison between the site and sponsor
Prepared for all monitoring visits by ensuring that all documents are filed and organized as well as resolving all previous outstanding regulatory issues
Maintain regulatory documents electronically on the online research folder for access by all research staff.
Provide support (including administrative/clerical) and information to staff, and external sources related to current research projects.
Attend meetings and conferences related to research activities.
Interact and communicate professionally with other members of the clinical team and office personnel.
Maintain appropriate records of regulatory activities.
Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.
Review and adhere to department policies and procedures to maintain proficiency in operating guidelines.
Demonstrate willingness to assist co-workers in completion of daily tasks or special projects to support the department's efficiency including but not limited to, taking patient's vital signs and recording them legibly in the patient's medical records.
High School Diploma/GED is required. Bachelor's degree in science or a science-related field is preferred.

One (1) year of experience as a regulatory associate is required.
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.
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.with 915 licensed beds, 2,993 physicians, 4,700+ 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.