Location:

\nUnited, PENNSYLVANIA\nDetails\n

Posted:

Unknown\n

Location:

Salary:

Summary:

\nSummary here.\nDetails\n

Posted:

20-Jun-26\n

Location:

United States - Nationwide\n

Categories:

\nAcademic/Faculty\n

Internal Number:

18071\nJob Description\nThe 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.\nCalHeart, 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.\nAre you ready to be a part of breakthrough research?\nThis 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.\n

Primary Duties and Responsibilities:

\nResearches reference materials and summarizes research findings.\nReviews protocols and informed consent forms for completeness and compliance with regulations\nAssists in the preparation of new protocols\nCurrent knowledge of GCP guidelines including protection of human subjects and regulations relevant to the performance and conduct of clinical trials\nMaintain Regulatory Files for all Clinical Trials\nPrepare 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.\nPrepare and submit to sponsor FDA Form 1572, financial disclosures, CVs and medical licenses\nEnsures site is utilizing the current regulatory documents including the informed consent forms, protocols, forms, and investigator brochures\nParticipates in the weekly research meeting\nMaintains the SAE Table noting all SAEs reported to sponsor, including initial and follow-ups, as well as those reported to the IRB\nMaintain site delegation logs for all clinical trials\nAct as regulatory liaison between the site and sponsor\nPrepared for all monitoring visits by ensuring that all documents are filed and organized as well as resolving all previous outstanding regulatory issues\nReview of all signed informed consent forms to assure accuracy and make corrections as needed.\nMaintain regulatory documents electronically on the online research folder for access by all research staff.\nProvide support (including administrative/clerical) and information to staff, and external sources related to current research projects.\nAttend meetings and conferences related to research activities.\nAct as liaison and coordinate efforts with other departments and personnel.\nInteract and communicate professionally with other members of the clinical team and office personnel.\nMaintain appropriate records of regulatory activities.\nAdvise supervisor, physicians, administrator of potential or actual problems.\nParticipate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.\nReview and adhere to department policies and procedures to maintain proficiency in operating guidelines.\nMaintain confidentiality when performing all duties and responsibilities.\nDemonstrate 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.\nSeek guidance and direction, as necessary, for the successful completion of job duties, ask appropriate questions when in doubt.\nMaintain appropriate records, notification of time worked, vacations, seminars, and professional time commitments related to this position.\nQualifications\n

Education:

\nHigh School Diploma/GED is required. Bachelor's degree in science or a science-related field is preferred.\n

Experience and Skills:

\nOne (1) year of experience as a regulatory associate is required.\nHave excellent organizational and prioritization skills.\nAble to work carefully and efficiently under stressful situations.\nExcellent oral and written communication skills.\nAbility to deal effectively with many people.\nCreate a Job Match for Similar Jobs\nLogo\nAbout Cedars-Sinai Medical Center\nProviding healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.

Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competi...tive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.

There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.\nShow more\nShow less\nConnections working at Cedars-Sinai Medical Center\nMore Jobs from This Employer\nmain.hercjobs.org/jobs/22365454/clinical-research-associate-i-calheart\nReturn to Search Results","accountId","36305800","Cedars-Sinai Medical 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Clinical Research Associate I - CalHeart