Cedars-Sinai Clinical Research Coordinator II - Smidt Heart Institute (Chikwe Group) in Los Angeles, California
Grow your career at Cedars-Sinai!
The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment 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 an increasing 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!
The Clinical Research Coordinator II 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 accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or 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.
•Schedules 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 perform 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.
•May coordinate training and education of other personnel.
•May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
•May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
•May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
•May identify new research opportunities and present to investigators
•Participates in required training and education programs
Highschool diploma/GED required
- Bachelor's degree in related field preferred
- SOCRA or ACRP certification preferred
- 2 years clinical research or related experience required
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 II - Smidt Heart Institute (Chikwe Group)
Department: Heart Institute Operations
Business Entity: Academic / Research
Job Category: ,Academic/Research,Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
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.