Clinical Research Coordinator III - Smidt Heart Institute

Company: CEDARS-SINAI
Location: Alhambra
Posted on: March 11, 2023

Job Description:

Grow your career at Cedars-Sinai!The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.Join our team and use your expertise with an organization known nationally for excellence in research!Key Job ResponsibilitiesThe Clinical Research Coordinator III works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).Primary Duties and Responsibilities--- Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.--- Scheduling of patients 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 patient 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; present this information at regular research staff meetings.--- Notifies direct supervisor about concerns regarding data quality and study conduct.--- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.--- May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.--- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.--- Maintains research practices using Good Clinical Practice (GCP) guidelines.--- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.--- Participates in required training and education programs.--- Works with Training and Education Coordinator to ensure all staff is properly trained and certified.--- Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.--- Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.--- Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.--- Identifies new research opportunities and presents to investigators.--- Supervises other research staff.
Educational Requirements:- Highschool Diploma Required- Bachelor's degree in science or related field preferredLicenses:SOCRA or ACRP certification preferredExperience:4 years clinical research related experience requiredPhysical Demands: - Able to perform moderate lifting. -- Able to sit, stand and walk for prolonged periods of time. -- Able to read papers and online documents. -- Able to operate standard office equipment. -- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Working Title: Clinical Research Coordinator III - Smidt Heart Institute
Department: Heart Institute Operations
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Per Diem
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$34.24 - $58.21

Keywords: CEDARS-SINAI, Alhambra , Clinical Research Coordinator III - Smidt Heart Institute, Healthcare , Alhambra, California