Cedars-Sinai Clinical Research Coordinator II - Cancer Prevention and Control Program in Beverly Hills, California
Do you have a passion for helping human kind?
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 works 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.
As the Clinical Research Coordinator II for the CPCP, you will work independently providing study coordination support for prospective epidemiologic studies and clinical trials. Responsibilities may include screening of participants for protocol eligibility, presenting an overview of study motivation and procedures, participating in the informed consent process, administering questionnaires, scheduling and follow-up of research study participants, transporting bio-specimens from procedure rooms to the processing laboratory. You will responsible for accurate and timely data collection, documentation and entry, and reporting including timely response to investigators requests and participants’ questions and concerns.
As a CRC II, you will also be responsible for the following:
Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at research staff meetings.
Document on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintain accurate source documents related to all research procedures.
Schedule and participates in monitoring and auditing activities.
Schedule of patients for research visits and procedures.
Notify direct supervisor about concerns regarding data quality and study conduct.
Work 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.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for patient enrollment, and/or improving clinical research efficiency.
May identify new research opportunities and present to investigators
Conducts literature reviews and assists in the design of investigator-initiated studies including protocol design and development.
Work with PI to design and develop study related documents including questionnaires, Case Report Forms, manual of operations, and tracking forms for assigned studies.
Establishes data collection process for assigned studies and standardize data collection, including data flow, data management, data entry, error identification and correction.
Work closely with Principal Investigator (PI) to streamline research study implementation, enrollment, and tracking of study conduct and progress for assigned studies.
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.
Coordinates/implements patient specimen collection for research purposes
This position is eligible for the Employee Referral Program. See website for details: http://careers.cedars-sinai.edu/working-here/employee-referrals/
BA/BS degree, required
Four (4) years minimum of directly related experience
ACRP or SoCRA (or equivalent) certification preferred.
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.