Clinical Research Associate I - MIRIAD IBD Biobank & Database
Los Angeles, California
Overview
Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.
- Full-time & Per-Diem
- Level: Mid to Senior
- Travel: Minimal (if any)
- Glassdoor Reviews and Company Rating
Success Profile
What makes a successful Clinical Research Associate I - MIRIAD IBD Biobank & Database at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.
- Analytical
- Organized
- Deadline-oriented
- Adaptable
- Results-driven
- Problem-solver
Responsibilities
Requisition # 9879Job Description
Are you a passionate and dedicated research professional?
The Material and Information Resources for Inflammatory and Digestive Diseases (MIRIAD) Biobank is the central hub of a full-circle approach to the study of inflammatory bowel disease (IBD). MIRIAD acquires, processes, stores, evaluates and distributes human specimens, which are maintained in association with the triad of accurate longitudinal clinical metadata, comprehensive genotype information and serotypes. These resources are made available to research partners within IBIRI and Cedars-Sinai, and with collaborators around the world.
Specimens have been collected from thousands of subjects over 3 decades. Clinical and research data are stored in an extensive database/LIMS system customized specifically for this purpose. The database is also used to monitor subject participation, assure regulatory compliance and to manage inventory. Collectively, MIRIAD's capabilities permit the rapid assembly and dispersal of homogenous cohorts for investigation.To learn more, please visit: MIRIAD IBD Biobank & Database | Cedars-Sinai.
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and Responsibilities:
- Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
- Evaluates and abstracts clinical research data from source documents.
- Ensures compliance with protocol and overall clinical research objectives.
- Completes Case Report Forms (CRFs).
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Provides supervised patient contact or patient contact for long term follow-up patients only.
- Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Assists with clinical trial budgets.
- Assists with patient research billing.
- Schedules patients 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.
Department-Specific Responsibilities:
- Understand and implement the current IRB/HIPAA regulatory rules and research protocol details.
- Communicate accurately and effectively with research subjects, clinicians, and researchers from diverse backgrounds.
- Work in various hospital environments during surgeries and endoscopies to obtain specimens for research.
- Assists with prescreening of potential research participants for various research projects and studies.
- Attends research meetings and monthly conference calls.
- Enter and maintain accurate patient/study data in databases.
- Database (LabVantage, Redcap) and advanced Excel spreadsheet entry of study resources in the process of sample banking.
- Perform laboratory procedures to prepare samples for further experiments, storage, or shipping, including DNA extraction and quantification from saliva and cell pellets.
- Collect specimens from an offsite location.
- Facilitate lab maintenance, coordinating with other lab personnel.
- This position may require on-site training by other experienced clinical research associates.
Qualifications
Education:
- High School Diploma/GED, is required. Bachelor's degree preferred.
Experience and Skills:
- One (1) year of clinical research related experience is preferred.
- Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
- Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
- Computer skills, including Word and Excel, and ability to use standard office equipment is required.
About Us
About the Team
Req ID : 9879
Working Title : Clinical Research Associate I - MIRIAD IBD Biobank & Database
Department : Research - Digestive and Liver Diseases
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $19.50 - $32.86
Our compensation philosophy
We offer competitive total compensation that includes pay, benefits, and other recognition programs for our employees. The base pay range shown above takes into account the wide range of factors that are considered in making compensation decisions including knowledge/skills; relevant experience and training; education/certifications/licensure; and other business and organizational factors. This base pay range does not include our comprehensive benefits package and any incentive payments that may be applicable to this role. Cedars - Sinai's EEO and AA Policy Statement
Diversity and Inclusion at Cedars-Sinai
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve – because that’s what our patients, colleagues and communities deserve. Quality Care and Research—For All, By All.
Cedars-Sinai is an Equal Employment Opportunity employer.
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy. Cedars - Sinai's EEO and AA Policy Statement
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