- High School Diploma/GED required
- SOCRA or ACRP certification preferred
- Bachelor's Degree Science, Sociology or related degree preferred
- 4 years of Clinical experience preferred
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Kidney Transplant Clinical Research Coord II - Los Angeles, United States - Cedars-Sinai
Description
Job Description
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 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.
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.
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.
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.
Qualifications
Qualifications:
Physical Demands:
Lifting, Sitting, Standing, Walking, Reading. Ability to operate office equipment. Able to exercise physical ability and perspective acuity to satisfactory perform essential job functions.
Req ID : 1435
Working Title :
Kidney Transplant Clinical Research Coord II
Department :
Research - Hepatology
Business Entity :
Cedars-Sinai Medical Center
Job Category :
Academic / Research
Job Specialty :
Research Studies/ Clin Trial
Overtime Status :
EXEMPT
Primary Shift :
Day
Shift Duration : 8 hour
Base Pay :
$58,864 - $100,068
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.
