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OneOncology · 1 day ago

Clinical Research Coordinator- Oncology/Gynecology

Laguna Hills, CA

Full-time

Hybrid

Entry Level

1+ years exp

OneOncology is focused on providing unparalleled care in cancer treatment and research. The Clinical Research Coordinator will be responsible for coordinating clinical studies, ensuring protocol compliance, and improving patient enrollment while maintaining accurate data documentation.

Health CareOncology

Growth Opportunities

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 in 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

Responsible to 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

Qualification

Clinical research coordinationClinical Practice (GCP)ACRP/SoCRA certificationData collectionPatient enrollment strategiesCommunication skillsTeam collaborationProblem-solving skillsAttention to detail

Required

1 year minimum of clinical research coordination experience, required

Preferred

BA/BS degree - Preferred

Experience in Women's Health, preferred

ACRP/SoCRA (or equivalent) certification preferred

Company

OneOncology

OneOncology is a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the US. It is a sub-organization of General Atlantic.

Founded in 2018

Nashville, Tennessee, USA

1001-5000 employees