Clinical Research Associate I - CalHeart

Cedars Sinai, Sinai, SD

About the role

The Clinical Research Associate supports clinical research protocols at CalHeart, affiliated with the Cedars-Sinai Smidt Heart Institute. This position assists the Research Department with all aspects of clinical research regulatory compliance and interacts with clinic staff, laboratory personnel, medical professionals, and pharmaceutical representatives.

Responsibilities

• Research reference materials and summarize findings.
• Review protocols and informed consent forms for completeness and compliance with regulations.
• Assist in the preparation of new protocols.
• Maintain current knowledge of GCP guidelines, including protection of human subjects and regulations relevant to clinical trials.
• Maintain Regulatory Files for all Clinical Trials.
• Prepare and submit documents to the IRB, including initial site submissions, continuing review reports, consents, amendments, investigator brochures, protocol deviations, SAE reports, IND safety reports, and close-out reports.
• Prepare and submit to sponsors: FDA Form 1572, financial disclosures, CVs, and medical licenses.
• Ensure the site utilizes current regulatory documents, including informed consent forms, protocols, forms, and investigator brochures.
• Participate in weekly research meetings.
• Maintain the SAE Table, noting all SAEs reported to sponsors and the IRB.
• Maintain site delegation logs for all clinical trials.
• Act as regulatory liaison between the site and sponsor.
• Prepare for monitoring visits by organizing documents and resolving outstanding regulatory issues.
• Review signed informed consent forms for accuracy and make corrections as needed.
• Maintain regulatory documents electronically in the online research folder for access by all research staff.
• Provide administrative and clerical support related to current research projects.
• Attend meetings and conferences related to research activities.
• Coordinate efforts with other departments and personnel.
• Maintain appropriate records of regulatory activities.
• Advise supervisors, physicians, and administrators of potential or actual problems.
• Participate in planning, workshops, evaluation meetings, and seminars as requested.
• Review and adhere to department policies and procedures.
• Maintain confidentiality in all duties and responsibilities.
• Assist co-workers with daily tasks or special projects, including recording patient vital signs in medical records.
• Seek guidance as necessary for successful completion of job duties.
• Maintain records of time worked, vacations, seminars, and professional commitments.

Requirements

• High School Diploma or 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.

Skills

• Excellent organizational and prioritization skills.
• Ability to work carefully and efficiently under stressful situations.
• Excellent oral and written communication skills.
• Ability to interact effectively with many people.