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Cedars-Sinai Clinical Research Coordinator III - Hepatology in Los Angeles, California

Are you looking to contribute to pioneering research? We look forward to having you join our team to collaborate on groundbreaking research!

The Cedars-Sinai Hepatology Program provides patients with comprehensive care for the full range of liver diseases ranging from benign to malignant disorders, in addition to offering expertise in the management of biliary diseases in a patient-centered and compassionate environment. Backed by a respected team of specialists and researchers, our clinical trials aim to further the advancement of diagnosing and treating your hepatology condition.

The Clinical Research Coordinator III 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. The incumbent will be responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. The Clinical Research Coordinator III plans and coordinates strategies for increasing research participant enrollment, improving efficiency, training of personnel, and identifying new research opportunities. The incumbent ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Essential Duties and Responsbilities:

  • 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.

  • Participates in required training and education programs.

  • Works with Training and Education Coordinator to ensure all staff is properly trained and certified.

  • 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.

  • Identifies new research opportunities and presents to investigators.

  • Supervises other clinical research staff in day to day operations. Provides input in the performance review of other clinical research staff.

Department-Specific Duties and Responsibilities:

  • Responsible for oversight of all studies within the group and the assignment of studies to clinical research personnel within the group.

  • Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.

  • Organizes and leads routine research meetings.

  • Works on both industry sponsor initiated and investigator initiated clinical trials.

  • Provides training to junior level coordinators.

  • Prepares and manages clinical trial budgets.

Education:

  • High School Diploma/GED, required

  • Bachelor's Degree, preferred

Licenses:

  • Certification in Clinical Research (SOCRA or ACRP certification) is highly preferred

Experience:

  • Minimum 4 years of clinical research related experience

Physical Demands:

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 Coordinator III - Hepatology

Department: Home Dept - Medicine Research

Business Entity: Academic / Research

Job Category: ,Academic/Research,Academic/Research

Job Specialty: Research Studies/Clinical Trials

Position Type: Full-time

Shift Length: 8 hour shift

Shift Type: Day

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.

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