[Remote] Clinical Research Associate I - CalHeart

Note: The job is a remote job and is open to candidates in USA. Cedars-Sinai is dedicated to integrating quality health care and clinical research at the California Heart Center. The Clinical Research Associate I will support clinical research protocols, ensuring compliance with regulations and maintaining regulatory files for clinical trials.ResponsibilitiesResearches reference materials and summarizes research findingsReviews protocols and informed consent forms for completeness and compliance with regulationsAssists in the preparation of new protocolsCurrent knowledge of GCP guidelines including protection of human subjects and regulations relevant to the performance and conduct of clinical trialsMaintain Regulatory Files for all Clinical TrialsPrepare 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 diariesPrepare and submit to sponsor FDA Form 1572, financial disclosures, CVs and medical licensesEnsures site is utilizing the current regulatory documents including the informed consent forms, protocols, forms, and investigator brochuresParticipates in the weekly research meetingMaintains the SAE Table noting all SAEs reported to sponsor, including initial and follow-ups, as well as those reported to the IRBMaintain site delegation logs for all clinical trialsAct as regulatory liaison between the site and sponsorPrepared for all monitoring visits by ensuring that all documents are filed and organized as well as resolving all previous outstanding regulatory issuesReview of all signed informed consent forms to assure accuracy and make corrections as neededMaintain regulatory documents electronically on the online research folder for access by all research staffProvide support (including administrative/clerical) and information to staff, and external sources related to current research projectsAttend meetings and conferences related to research activitiesAct as liaison and coordinate efforts with other departments and personnelInteract and communicate professionally with other members of the clinical team and office personnelMaintain appropriate records of regulatory activitiesAdvise supervisor, physicians, administrator of potential or actual problemsParticipate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requestedReview and adhere to department policies and procedures to maintain proficiency in operating guidelinesMaintain confidentiality when performing all duties and responsibilitiesDemonstrate 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 recordsSeek guidance and direction, as necessary, for the successful completion of job duties, ask appropriate questions when in doubtMaintain appropriate records, notification of time worked, vacations, seminars, and professional time commitments related to this positionSkillsHigh School Diploma/GED is requiredOne (1) year of experience as a regulatory associate is requiredHave excellent organizational and prioritization skillsAble to work carefully and efficiently under stressful situationsExcellent oral and written communication skillsAbility to deal effectively with many peopleBachelor's degree in science or a science-related field is preferredCompany OverviewSince its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service. It was founded in 1902, and is headquartered in Los Angeles, California, USA, with a workforce of 10001+ employees. Its website is https://www.cedars-sinai.org.Company H1B SponsorshipCedars-Sinai has a track record of offering H1B sponsorships, with 24 in 2026, 105 in 2025, 91 in 2024, 81 in 2023, 92 in 2022, 92 in 2021, 65 in 2020. Please note that this does not guarantee sponsorship for this specific role.