Clinical Research Associate II

Job Description

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.

Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered.

Cedars-Sinai has an outstanding opportunity for an independent and well-organized contributor to serve as a CLINICAL RESEARCH ASSOCIATE II to Dr. Judy Tan to support community-engaged research that develops behavioral and community-based health interventions for LGBTQ+ communities of color. Dr. Tan, Associate Professor, Cancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, is a social psychologist and applies her training in behavioral and prevention sciences to develop innovative interventions for improving health outcomes among marginalized populations in the U.S.

This position provides contributions to behavioral and implementation science for the Cancer Research Center for Health Equity. The scope of the work includes research involving participants recruited from the surrounding LA communities and interactions with community-based researchers, academic researchers, and local community organizations and health systems.

The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. May serve independently as study coordinator for minimal number of noncomplex research studies or projects.

Responsibilities:

• Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies.
• Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently.
• Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines.
• Assists with clinical trial budgets and patient billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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 serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities.
• Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives.
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
• May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives.

Qualifications

Education

• High School Diploma/GED - minimum
• Bachelor's Degree Science, Sociology or related degree. - preferred

Experience

• 1 year Clinical research related. - minimum

Licenses and Certifications

• Certification In Clinical Research - preferred SOCRA or ACRP certification