Clinical Research Specialist - Cancer Clinical Trials Office Lab

Cedars Sinai Los Angeles , CA 90009

Posted 2 months ago

Share Requisition # HRC0478019

At Cedars-Sinai, we're motivated by a collective spirit of innovation and the challenge to continuously improve. Above all, we share a real passion for helping others. Day after day, from department to department, our people give their all to create a community unlike any other. This is just one of the many reasons U.S. News & World Report has named us one of America's Best Hospitals-and now we invite you to join us and make a difference every single day in service of this outstanding work - excellence and innovation in patient care, research, and community service. From working with a team of dedicated professionals to using state-of-the-art facilities, you'll have great resources to do something incredible-for yourself, and for others.

Join our team and expand your skills and knowledge! You will 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 researchers develop some of the most advanced clinical trials in the world. Here, you will be a part of leading-edge cancer research history that improves and enhances our patients' treatment options, one trial at a time.

Job Summary:

The Clinical Research Specialist I provides clinical research knowledge by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates updates and improvement areas to leadership.


Essential Job Duties and Responsibilities:
  • Coordinates research projects at an institutional or departmental level.

  • 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.

  • 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.

  • 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 Job Responsibilities:

  • Acts of the point person for all sponsors including SIVs, monitoring visits, etc. and communicates any protocol questions or concerns to sponsor and manager in a timely manner.

  • Develops and submits monthly CRO laboratory invoices for IITs.

  • Develops budgets for newly initiated IITs and facilitates agreements.

  • Develops kit inventory system and maintains adequate level of kits and supplies for the conduct of research sample collection.

  • Develop laboratory manuals in conjunction with the Protocol Development Core and PIs including lab manual design, writing, editing, case report form development.

  • Collect and analyze research sample data related to workflow, volume, etc. and makes recommendations on improvement of systems.

  • Integrates OnCore BSM module and clinical module into everyday workflow including the adoption of specimen labels and the implementation of reports to identify daily kits required.

  • Manage the day to day workflow of the CRO Laboratory.

  • Responsible for sample preparation and shipping for sponsored research studies and Investigator Initiated Trials.

Qualifications

  • External

Educational Requirements:

  • BA/BS degree, required.

License/Certification Requirements:

  • ACRP/SoCRA (or equivalent) certification preferred.

Experience:

  • Three (3) years minimum experience in area of research specialty.

  • Working Title: Clinical Research Specialist

  • Cancer Clinical Trials Office Lab
  • Department: SOCCI Clinical Research Office

  • Business Entity: Academic / Research

  • City: Los Angeles

  • Job Category: Academic/Research

  • Job Specialty: Research Studies/Clinical Trials

  • Position Type: Full-time

  • Shift Length: 8 hour shift

  • Shift Type: Full-time

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). 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 March each year) as a condition of employment, and annually thereafter as a condition of continued employment.

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Qualifications: Education * BA/BS degree, required. License/Certification/Registration Requirements * ACRP/SoCRA (or equivalent) certification preferred. Experience * Three (3) years minimum experience in area of research specialty. * Working Title: Clinical Research Specialist I - Cancer Clinical Trials Office * Department: SOCCI Clinical Research Office * Business Entity: Academic / Research * 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. 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Clinical Research Specialist - Cancer Clinical Trials Office Lab

Cedars Sinai