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Cedars-Sinai · 2 days ago

Clinical Research Coordinator II, Hybrid

Beverly Hills, CA

Full-time

Hybrid

Entry, Mid Level

$28.30/hr - $48.11/hr

2+ years exp

Cedars-Sinai is a prominent medical center seeking a Clinical Research Coordinator II to oversee study coordination and ensure compliance with federal regulations. This role involves screening potential patients, managing data collection, and reporting on research activities while collaborating with medical personnel and regulatory bodies.

CommunitiesHealth CareMedicalNon Profit

Comp. & Benefits

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. Primary Duties and Responsibilities

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

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

Transportation of research medications

Performs research study related assessments and questionnaires

Assists with prescreening of potential research participants for various clinical trials

Attends research meetings and monthly conference calls with sponsors for study updates

Maintains organized paper and electronic research files

Performs all data collection and data entry tasks for department clinical trials

Assists with preparing manuscripts, letters, and other research documents as needed

Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment

Performs literature reviews

Assists with budget development and negotiation in partnership with CTAO and sponsors to ensure budgets are fully compliant with all CSMC policies

May facilitate training and education of other personnel including mentorship for junior research staff to improve workflow efficiencies

Qualification

Clinical research experienceClinical Practice (GCP)Data collectionRegulatory compliancePatient enrollment strategiesTrainingCommunication skillsTeam collaborationMentorship

Required

High School Diploma/GED

2 years Clinical research related experience

Preferred

Bachelor's Degree

Company

Cedars-Sinai

Glassdoor4.0

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.

Founded in 1902

Los Angeles, California, USA

10001+ employees