Clinical Research Associate II

Cedars-Sinai•Los Angeles, CA

3d•$25 - $37

About The Position

The Clinical Research Associate II works independently with minimal direction and in close collaboration with Clinical Research Coordinators, Research Program Administrators, Research Nurses, and other supervising staff to coordinate and implement increasingly complex research studies. The role supports study objectives through data collection, participant prescreening and scheduling, IRB submission assistance, budget and billing support, and compliance with federal and local requirements. The position also provides increasingly independent support, including serving as a contact for sponsors, the IRB, and research participants; training and educating junior staff; and coordinating ad hoc study activities. The Clinical Research Associate II may independently coordinate a limited number of noncomplex studies or projects.

Requirements

High school diploma or GED.
At least 1 year of clinical research-related experience.

Nice To Haves

Bachelor's degree in Science, Sociology, or a related field.
Clinical research certification, such as SOCRA or ACRP certification.

Responsibilities

Work independently under minimal direction from supervising research staff to coordinate and implement increasingly complex research studies.
Collect, evaluate, and abstract clinical research data; assist with designing data collection or abstraction forms; and enter and process data in sponsor-provided electronic data systems.
Complete Case Report Forms (CRFs).
Independently prescreen potential research participants, schedule visits and procedures, and, where appropriate, contact participants or conduct visits independently.
Assist supervising staff with Institutional Review Board (IRB) regulatory submissions and, when applicable, submit adverse events, serious adverse events, and safety letters in accordance with local and federal guidelines.
Assist with clinical trial budgets and patient billing.
Prepare and ship samples and maintain study supplies and kits.
Ensure compliance with study protocols, research objectives, applicable federal and local requirements, Good Clinical Practice guidelines, and HIPAA confidentiality requirements.
Serve as the primary contact for external sponsors on select trials, respond to sponsor inquiries, and attend study activity meetings.
Participate in and provide training and education to other Clinical Research Associates, and help coordinate their activities to support protocol compliance and study objectives.
Participate in centralized activities such as auditing and Standard Operating Procedure development.
May participate in developing investigator-initiated trials for Investigational New Drug or device applications.
May independently coordinate a limited number of noncomplex studies or projects and provide coverage for supervising staff's study coordination activities when needed.