Cedars-Sinai Clinical Research Coordinator II - Biomedical Imaging Research Institute in Los Angeles, California
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The Cedars-Sinai Biomedical Imaging Research Institute (BIRI) is an interdisciplinary research program established to develop and apply state-of-the-art imaging technologies to today’s most pressing translational research and clinical questions, and is currently seeking a Clinical Research Coordinator II to join the team!
Essential job duties and responsibilities:
As a CRCII, you will work independently providing study coordination for several Institute faculty, to include recruitment, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
Additional responsibilities include:
Scheduling of research participants 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 research participant 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, and presenting this information at regular research staff meetings
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines
May involve other regulatory/IRB duties, budgeting duties, and assisting with research participant billing and reconciliation
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB
Maintains research practices using Good Clinical Practice (GCP) guidelines
Maintains strict research participant confidentiality according to HIPAA regulations and applicable law, and coordinates training and education of other personnel
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans, coordinates, and participates strategies for increasing research participant enrollment, and/or improving clinical research efficiency
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality
May identify new research opportunities and present to Investigators
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- Bachelors degree (BA or BS) required
- ACRP or SoCRA (or equivalent) certification preferred
Experience and Expertise:
Four (4) years minimum of directly related experience in the field of clinical trial coordination
MS Office computer skills, data extraction and entry skills, and the ability to become proficient using related organizational and sponsor software programs
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.