Clinical Research Associate I - CalHeart

Job Description

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.

Primary Duties and Responsibilities:

• Researches reference materials and summarizes research findings.
• Reviews protocols and informed consent forms for completeness and compliance with regulations
• Assists in the preparation of new protocols
• 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
• Maintains the SAE Table noting all SAEs reported to sponsor, including initial and follow-ups, as well as those reported to the IRB
• 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
• Review of all signed informed consent forms to assure accuracy and make corrections as needed.
• 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.
• Act as liaison and coordinate efforts with other departments and personnel.
• Interact and communicate professionally with other members of the clinical team and office personnel.
• Maintain appropriate records of regulatory activities.
• Advise supervisor, physicians, administrator of potential or actual problems.
• 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.
• Maintain confidentiality when performing all duties and responsibilities.
• 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.
• Seek guidance and direction, as necessary, for the successful completion of job duties, ask appropriate questions when in doubt.
• Maintain appropriate records, notification of time worked, vacations, seminars, and professional time commitments related to this position.

Qualifications

Education:

• High School Diploma/GED is required. Bachelor's degree in science or a science-related field is preferred.

Experience and Skills:

• One (1) year of experience as a regulatory associate is required.
• Have excellent organizational and prioritization skills.
• Able to work carefully and efficiently under stressful situations.
• Excellent oral and written communication skills.
• Ability to deal effectively with many people.