Clinical Research Associate II - Obstetrics & Gynecology - Minimally Invasive Gynecologic Surgery (Full-Time, Hybrid)
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.
- I
- 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 II - Obstetrics & Gynecology - Minimally Invasive Gynecologic Surgery (Full-Time, Hybrid) 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
Culture
Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.
Responsibilities
Requisition # 4375Job Description
Come join our team!
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 assist with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for study and assist 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.
What are the Primary Duties and Responsibilities?
- Works with a Clinical Research Coordinator,Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement 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
Qualifications
Educational Requirements:
- High School Diploma/GED required
- Bachelor's Degree in Science, Sociology or related degree preferred
ExperienceRequirements:
- One (1) year of clinical research related experience required
License & Certification Requirements:
- Certification in Clinical Research (SOCRA or ACRP) preferred
About Us
About the Team
Req ID : 4375
Working Title : Clinical Research Associate II - Obstetrics & Gynecology - Minimally Invasive Gynecologic Surgery (Full-Time, Hybrid)
Department : Womens Cancer Program - WCP
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 : $21.26 - $36.14
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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Rewards
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401(K)/Retirement Plans
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Continuing Education
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