The Hitchins Laboratory undertakes translational cancer research with a focus on genetic and epigenetic alterations associated with cancer, in particular cancer-specific changes in DNA methylation. Researchers in the Hitchins Lab undertake studies on genetic and epigenetic alterations that predispose to cancer onset, as well as the discovery and development of epigenetic alterations to serve as tumor biomarkers for applications to cancer diagnosis, prognosis or prediction of treatment outcomes. To learn more, please visit: Hitchins Lab | Cedars-Sinai

The Hitchins Lab is seeking a Clinical Research Coordinator (CRC) to provide study coordination, screening of potential patients for protocol eligibility, presentation of non-medical trial concepts and details and participation in the informed consent process. The CRC will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Position may also require sample processing, sample collection/phlebotomy, and off-site sample pick up and consenting.

Primary Job Duties and Responsibilities:

• 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.
• Scheduling of patients for research visits and procedures.
• Maintains accurate source documents related to all research procedures.
• 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 IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May involve other regulatory / IRB 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 (IRB).
• 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 Responsibilities:

• Performs phlebotomy services according to CSMC policies and procedures.
• Verifies specimen identification, assesses the appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated.
• Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely.
• Reports test results to appropriate individuals and exercise professional discretion with patient information.

Education:

• High School Diploma/GED, required. Bachelor's Degree in Science, Sociology or related field is preferred.

Licenses and Certifications:

• Certification In Clinical Research (SOCRA or ACRP) is preferred.
• CA Phlebotomy Certification (CPT) or willingness to obtain upon hire preferred.

Experience and Skills:

• One (1) year of clinical research related experience.
• Clinical/medical background or other experience with patient care, and basic knowledge of medical terminology preferred.
• Ability to use discretion and maintain privacy, confidentiality or anonymity.
• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

Working Title: Clinical Research Coordinator I - Hitchins Lab - Biomedical Sciences
Department: BMS - Bioinfo & Func Genomics
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$22.27 - $37.87