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Clinical Research Specialist

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.

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Success Profile

What makes a successful Clinical Research Specialist 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

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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.

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Responsibilities

Requisition # HRC0749668

Join Cedars-Sinai!

Align yourself with an organization that has a reputation for excellence! Cedars Sinai was awarded the National Research Corporation’s Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles. We also were awarded the Advisory Board Company’s Workplace of the Year. This annual award recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement. We provide an outstanding benefits package, along with competitive compensation. Join us! Discover why U.S. News & World Report has named us one of America’s Best Hospitals.

The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. We are committed to bringing innovative therapeutic options to all our patients with cancer. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care!

What will you be doing in this role?

The Clinical Research Specialist provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed.  Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership.  May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.  Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Duties and Responsibilities:

  • Provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed by the department or institution.
  • Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
  • Coordinates research projects at an institutional or departmental level. Serves as an internal consultant for specific departmental activities.
  • Communicates project status and improvement areas with leadership in a timely manner. Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
  • Implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
  • Provides guidance regarding project planning, project logistics, and project implementation
  • Participates in required training and education programs. Participates in weekly research staff meetings.
  • Provides clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance.
  • Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according FDA, HSPC, HIPAA an d other agency guidelines.
  • Completes appropriate IRB paperwork and submission/filing of internal and external SAEs to IRB. Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.
  • Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to monitor and update project progress.
  • Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
  • Attends site feasibility visits and site initiation visits for potential studies, and assures that new studies are implemented according to protocol.
  • Review pertinent medical records to determine opportunities for quality improvement.   Analyze quality metric data in support of the Principal Investigator and Director of Clinical Services. Recommend and implement process improvement efforts.
  • Assists with procedures, and supports related patient care when required during data collection process. Serves as a resource and mentor to other research staff by providing training, work review and leading staff.
  • Provides guidance, instruction and expertise to team members on study requirements and clinical coordination of the studies.
  • May assist with grant proposals, publication preparation, and/or presentations.
  • May process, ship, track or otherwise handle research specimens.

Work Experience:

  • 5+ years in area of clinical research
  • 5+ years in IRB clinical research application procedures. Related experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO) preferred
  • 5+ years in Phase I, II, III, IV clinical trials and investigator initiated trials preferred

Licenses and Certifications:

  • BLS
  • Certification in Clinical Research (SOCRA or ACPR)
  • Phlebotomy certification CA preferred
  • Certified registered Medical Assistant preferred
  • Working Title: Clinical Research Specialist
  • Department: Angeles Research
  • Business Entity: Medical Network Foundation
  • City: Los Angeles
  • Job Category: Academic/Research
  • Job Specialty: Research Studies/Clinical Trials
  • Position Type: Full-time
  • Shift Length: 8 hour shift
  • Shift Type: Day

Cedars-Sinai is an EEO 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.

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Rewards

Discover all the ways Cedars-Sinai appreciates your efforts.

  • Healthcare

  • 401(K)/Retirement Plans

  • Continuing Education

  • Relocation Reimbursement

  • Professional Development

  • Work/life Balance

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