Clinical Research Coordinator I with CA Phlebotomy Certification- Cancer Prevention & ControlRequisition # 19002945 Apply Now
The Cancer Prevention and Control Program at Cedars-Sinai conducts multi-disciplinary research projects prioritizing molecular epidemiological approaches to cancer prevention, risk assessment, treatment and rehabilitation. A central focus of the Program is to translate laboratory and population health research at Cedars-Sinai Medical Center into clinical interventions that slow the progression of cancer, reduce the toxicity of cancer treatment, and enhance the quality of life in our patients. Our team interfaces with a diverse array of research participants, including healthy volunteers, people at risk for cancer, people with liver disease, transplant recipients, individuals with breast, colorectal, liver or pancreatic cancers, and individuals with pancreatitis and diabetes.
The Clinical Research Coordinator I 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; present this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
ESSENTIAL JOB 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 including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
Performs phlebotomy services according to CSMC policies and procedures.
Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated.
Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely.
Reports test results to appropriate individuals and exercises professional discretion with patient information.
DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
May be trained on study related machine/equipment and procedures by either study sponsor, PI, or PI designee, if necessary for research study.
May conduct non-invasive clinical assessments (e.g., vital signs, Fibroscan) for research purposes, if applicable, according to Cedars-Sinai policies.
This position is eligible for the Employee Referral Program. See website for details: http://careers.cedars-sinai.edu/working-here/employee-referrals/
BA degree, Required
Current and Valid California Phlebotomy certification, Required
Two (2) years of directly related experience, Required
- Working Title: Clinical Research Coordinator I with CA Phlebotomy Certification- Cancer Prevention & Control
- Department: SOCCI Clinical Research Office
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic / Research
- Job Specialty: Research Studies / Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Full-time
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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.
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