Clinical Research Associate II - Melmed Lab - Inflammatory Bowel Disease
Los Angeles, CA
Job posting number: #7186170 (Ref:HRC1401307)
Posted: October 11, 2023
Application Deadline: Open Until Filled
Principal Investigator, Dr. Gil Melmed is seeking a Clinical Research Associate to join the team!
Cedars-Sinai is home to some of the most advanced biomedical research and training programs in the world, which attracts renowned physician-scientists seeking an unparalleled environment for fostering invention and teamwork.
The research of Dr. Gil Melmed focuses on clinical outcomes research in inflammatory bowel disease. Specifically, he is interested in improving health outcomes, health-related quality of life, and quality of care. His research includes the role of vaccination in preventing infection, IBD disease phenotype and classification, and outcomes after surgery. Dr. Melmed oversees clinical trials of novel agents for Crohn's disease and ulcerative colitis.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for the study and assists with study budget and patient research participant research billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties & Responsibilities:
- Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement the study.
- Evaluates and abstracts clinical research data from source documents.
- Completes Case Report Forms (CRFs).
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Provides supervised contact with research participants or contact for long term follow-up research participants only.
- Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Assists with clinical trial budgets.
- Schedules research participants for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- 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.
- Participates in required training and education programs. May be involved in training and education of other Clinical Research Associates.
- Serves as the point of contact for external sponsors for select trials.
- Coordinates activities of other associates to ensure compliance with protocol and overall 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.
- Responsible for the procurement and maintenance of laboratory supplies, ensuring an uninterrupted workflow.
- Oversee the receipt and tracking of shipments and orders, ensuring timely delivery and accurate documentation.
- Conduct laboratory procedures to prepare samples for subsequent experiments, storage, or shipping, adhering to established protocols.
- Coordinate lab maintenance activities and collaborate with other lab personnel to ensure a safe and organized work environment.
- Stay informed about and implement current IRB/HIPAA regulatory rules and adhere to research protocol requirements in all activities.
- Enter and maintain accurate patient/study data in databases, ensuring data integrity and security.
- Communicate clearly and effectively with sponsors, research subjects, clinicians, and researchers, maintaining professionalism and sensitivity to diverse backgrounds.
Department-Specific Licenses and Certifications:
- CA Certified Phlebotomy Technician I (CPT1) is required.
- Valid Driver's License is required.
- High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or related field.
Experience and Skills:
- One (1) year of clinical research related experience is required.
- Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
Working Title: Clinical Research Associate II - Melmed Lab - Inflammatory Bowel Disease
Department: Home Dept - Gastroenterology
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$21.26 - $36.14