Cedars Sinai

Job Description

Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!

Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world. Ranked among the best in the nation by U.S. News & World Report, our neurosurgeons and neurologists work together with experienced care teams to give patients the most effective treatment possible.

About the Team

The Pandol Lab in the Cedars-Sinai Pancreatic Research Program is concentrating efforts to better understand the molecular mechanisms of pancreatic diseases and develop new prevention, diagnostic and effective treatments for these diseases. The Pancreatic Research Program's multidisciplinary team consists of molecular biologists, cell biologists, computational chemists, population scientists, clinical scientists and physicians, all working toward the common goal of enhanced treatments and outcomes for pancreatic cancer, pancreatitis and diabetes patients.

About the Role

The Clinical Research Coordinator II works independently providing study coordination in support of The Pancreatic Research Program's multidisciplinary team's larger goal of enhancing treatments and outcomes for pancreatic cancer, pancreatitis, and diabetes patients. This position is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is also responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent is expected to present information at research staff meeting, may plan and coordinate strategies for increasing patient enrollment, improving efficiency, and training of personnel. The incumbent ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

• Screening of patients for protocol eligibility, presenting non-medical trial concepts and details.
• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
• Maintains accurate source documents related to all research procedures.
• Schedules and participates in monitoring and auditing activities.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Participates in required training and education programs.

Qualifications

Education:

• High School Diploma/GED is required.
• Bachelor's degree is preferred.

Licenses:

• ACRP/SoCRA (or equivalent) certification, preferred.

Experience:

• Two years of clinical research related experience is required.

About Us

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

About the Team

Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.

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). 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 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 AA Policy Statement (PDF)