Cedars-Sinai Clinical Research Coord II in Los Angeles, California

Clinical Research Coord II Requisition # 29718

JOB SUMMARY:

The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

Scheduling of patients for research visits and procedures.

In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

Maintains accurate source documents related to all research procedures.

Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

Schedules and participates in monitoring and auditing activities.

Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.

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 involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.

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.

May coordinate training and education of other personnel.

May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.

May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.

May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.

May identify new research opportunities and present to investigators

Participates in required training and education programs.

DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:

Manages regulatory files for clinical trials and clinical research projects

Initiates study start up by completing regulatory documents from sponsors and CROs

Prepares IRB study applications for Rheumatology faculty

Prepares annual continuation reviews to the IRB

Prepares adverse event and serious adverse event reports to the IRB, sponsor/CRO, and other agencies (FDA) by required timelines. Submits SUSAR reports to the IRB if they meet IRB reporting requirements.

Prepares and submits protocol deviation reports and protocol exemption requests to the IRB

Prepares protocol amendments for IRB review

Constructs informed consent forms for studies using the CSMC IRB template

Participates in monitoring and auditing activities

Manages clinical research databases, data registries, and specimen repositories

Travels to Attune Health to assist with patient recruitment

Educational Requirements:

BA/BS degree.

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Four (4) years minimum of directly related experience.

Physical Demands: (e.g., lifting, standing, walking)

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.

Qualification Requirements/Preferences:

Education Certifications/Licensure Experience Physical Abilities Educational Requirements:

BA/BS degree.

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Four (4) years minimum of directly related experience.

Physical Demands: (e.g., lifting, standing, walking)

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 Coord II
  • Business Entity: CSMC - Cedars-Sinai Medical Center
  • Cost Center # - Cost Center Name: 0801108 - Home Dept - Medicine Research
  • City: Los Angeles
  • Job Category: Research/Research Admin
  • Job Specialty: Clinical Research
  • Position Type: Regular-F/T
  • Shift Length: 8hr
  • Hours: 8:30am - 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.