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

Clinical Research Coord II Requisition # 29744

JOB SUMMARY:

The Clinical Research Coordinator II works independently providing study coordination including screening of potential research participants 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; presents this information at regular research staff meetings. May plan and coordinate strategies for increasing research participant 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 research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.

Scheduling of research participants 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 research participant 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 initial applications, amendments, continuing reviews, 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 research participant 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 research participant confidentiality according to HIPAA regulations and applicable law.

Coordinates training and education of other personnel.

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

Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.

Identifies quality and performance improvement opportunities and collaborates 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:

Will be expected to perform the following department specific job responsibilities related to the Fatty Liver Disease Program:

Supervise junior level coordinators, assist in growing and maintaining program research databases (Informational and Human Sample). Willingness to work evenings or to vary hours in order to coordinate study visits, juggling of multiple tasks/responsibilities, and good organizational skills.

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 experience.

Experience coordinating Phase 1, 2 and 3 clinical trials preferred.

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

All apply

  • 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: As Needed

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.