Clinical Research Coordinator I - Heart Institute - Makkar Team

Job Description

Grow your career at Cedars-Sinai!

Cedars-Sinai Medical Center has been named to the Honor Roll in U.S. News & World Report’s “Best Hospitals 2025-2026” rankings . When you join our team, you’ll have access to groundbreaking biomedical research facilities and world-class medical education programs. We take pride in hiring exceptional, dedicated professionals who are passionate about advancing healthcare. Our physicians, nurses, and staff reflect the culturally and ethnically diverse communities we serve and are united by a shared commitment to excellence. Together, we foster a dynamic, inclusive environment that drives innovation and supports the gold standard of patient care.

Are you ready to be a part of breakthrough research?

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.

What will you be doing in this role?

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study 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).

Primary Duties & 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.

• Schedules patients 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 patient 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 regular 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 Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.

• 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.

Qualifications

Education:

• High School Diploma is required.

• Bachelor's degree preferred in Science, Sociology, or related field.

Licenses/Certifications:

• Certification in Clinical Research from SOCRA or ACRP certification is preferred.

Experience and Skills:

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

• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.

• Ability to use discretion and maintain privacy, confidentiality or anonymity.

• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.