Cedars-Sinai Clinical Research Specialist I (Cancer Prevention and Control Program) in Los Angeles, California

Clinical Research Specialist I (Cancer Prevention and Control Program) Requisition # 29727

The Cancer Prevention and Control Program at Cedars-Sinai conducts multi-disciplinary research projects prioritizing molecular epidemiological approaches to cancer prevention, risk assessment, treatment and rehabilitation. A central focus of the Program is to translate laboratory and population research at Cedars-Sinai Medical Center into clinical interventions that slow the progression of cancer, reduce the toxicity of cancer treatment, and enhance the quality of life in our patients. Our team interfaces with a diverse array of patients, including people with liver disease, transplant recipients, individuals with breast, colorectal, liver or pancreatic cancers, and individuals with pancreatitis and diabetes.

The Clinical Research Specialist I provides clinical research expertise by participating in the design and implementation of research projects as needed. Research projects may include epidemiologic studies such as population-based and clinic-based studies and intervention trials focusing on cancer and related conditions. 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). Assists in preparing grants and manuscripts including basic statistical analyses.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Provides clinical research expertise by participating in the design and implementation of research projects 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.

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 AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:

Work closely with Principal Investigator (PI) to oversee research study implementation, enrollment, and tracking of study conduct and progress for assigned studies, including those with multi-site participation.

Work with PI and co-investigators to design and develop the protocol, template informed consent documents, case report forms, and manual of operations, for assigned studies, and if applicable, for multi-site participants.

Oversee the development of study related documents, such as patient questionnaires, Case Report Forms, manual of operations (e.g., pharmacy, laboratory), and tracking forms with the study team.

Establish data collection process for assigned studies and standardize data collection, including data flow, data management, data entry, error identification and correction.

Maintain regulatory documentation including new project submissions, continuations, and amendments which may include Investigator-Initiated Trial Working Group, Protocol Prioritization Committee, Protocol Review and Monitoring Committee, and IRB submissions.

For multi-site studies, assist other participating sites with regulator binders, if applicable, by communicating protocol amendments and distributing records of IRB submissions, approvals, and expiration dates; provide guidance or review on IRB forms and track annual review across all study sites.

Oversee training of internal staff on study protocol and provide support for staff at other study sites for multi-site studies, if applicable; tasks may include study initiation visits, protocol and amendment training.

For assigned studies, maintain routine communication with study teams (e.g., monthly conference calls, quarterly steering committee meetings, team meetings). Provide and distribute monthly reports on participant enrollment, general study progress, and relevant scientific advances.

Work in conjunction with the PI to secure compliance at external sites that are not adhering to the current version of the research protocol and/or good clinical research practices and ensure deadlines for data and study implementation are met.

Conducts literature reviews and assists in the design and implementation of investigator initiated studies including protocol design and development, and grant submissions.

Qualification Requirements/Preferences:

Education Certifications/Licensure Experience Physical Abilities Education:

BA/BS degree required. MPH or equivalent with experience in epidemiologic research preferred.

Certification/License:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

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

Physical Requirements (physical abilities essential to perform the job)

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

  • Working Title: Clinical Research Specialist I (Cancer Prevention and Control Program)
  • Business Entity: CSMC - Cedars-Sinai Medical Center
  • Cost Center # - Cost Center Name: 0879006 - SOCCI Clinical Research Office
  • City: Los Angeles
  • Job Category: Research/Research Admin
  • Job Specialty: Clinical Research
  • Position Type: Regular-F/T
  • Shift Length: 8hr
  • Hours: 9am - 5pm
  • Days: Monday - Friday
  • Shift Type: Day
  • Weekends: None

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.