Clinical Research Coordinator II (Hybrid)

National Medical Association; California (MO); Hybrid; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Research Coordinator II to join their dynamic team. This exciting role involves coordinating clinical trials, ensuring compliance with regulations, and managing patient data. The ideal candidate will have a strong background in clinical research and a passion for improving patient outcomes. This position offers a hybrid work schedule, allowing for flexibility while maintaining a strong connection to the research team. If you're looking to make a meaningful impact in the field of clinical research, this opportunity is perfect for you.

Qualifications

• 2 years of clinical research experience required.
• High School Diploma/GED required; Bachelor's preferred.

Responsibilities

• Coordinate clinical research studies and manage patient data.
• Ensure compliance with FDA and IRB regulations.
• Schedule and document patient visits and procedures.

Skills

Clinical Research Coordination

Data Collection and Documentation

Patient Screening

Regulatory Compliance

Good Clinical Practice (GCP)

Education

High School Diploma/GED

Bachelor's Degree in Science or Sociology

Job description

Job Description

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

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. Presents 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).

Primary 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.
• Schedules 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 perform 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.

Qualifications

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

Requirements:

• High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
• 2 years Clinical research related experience required.

#Jobs-Indeed

Req ID : 8277
Working Title : Clinical Research Coordinator II (Hybrid)
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $28.30 - $48.11