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Clinical Research Coordinator II - Cedars-Sinai Medical Group

CEDARS-SINAI
Sacramento, CA Full Time
POSTED ON 1/23/2025
AVAILABLE BEFORE 4/22/2025

Job Description

Are you ready to be a part of breakthrough research?

The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements.

Primary Duties and Responsibilities :

  • Establishes and executes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
  • Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures, and labs, and completion and maintenance of consent forms, case report forms, SAE’s, and source documents.
  • Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
  • Responsible for accurate and timely data collection, documentation, entry, and reporting, including resolution of queries from sponsors or regulatory entities.
  • Coordinates institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designs and implements needed corrective actions.
  • 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.
  • Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
  • Plans and coordinates strategies for increasing research participant enrollment, and / or improving clinical research efficiency as needed.
  • Provides technical support for the preparation of grant proposals, publications, presentations, and special projects.
  • Provides assistance with research project budget development, including identifying and classifying routine care vs. research-related care, and provides assistance with research participant research billing and reconciliation.
  • Attend meetings and conferences related to research activities, including research staff meetings.
  • Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; Participate in training and education of new research personnel.

Qualifications

Education :

  • An Associate Degree / College Diploma is required. Bachelor's degree preferred.
  • Licenses and Certifications :

  • Basic Life Support (BLS) is required.
  • Certification In Clinical Research (SoCRA or ACRP certification), Phlebotomy Certification (CA), and Certification as a Registered Medical Assistant are preferred.
  • Experience and Skills :

  • Three (3) years of clinical research coordination or related experience is required.
  • Maintains comprehensive knowledge of assigned research protocols to coordinate the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
  • Ability to use software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.).
  • Establishes effective working relationships with cross-functional team(s).
  • Collaborates to solve problems and make decisions to achieve desired outcomes.
  • Cultivates and maintains strong customer relationships and rapport with stakeholders and / or client groups.
  • Identifies and responds appropriately to internal and external customer needs utilizing available resources.
  • Represents the company with external constituents.
  • About Us

    Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

    About the Team

    With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai’s medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.

    Req ID : 6853

    Working Title : Clinical Research Coordinator II - Cedars-Sinai Medical Group

    Department : Research - CSMN

    Business Entity : Cedars-Sinai Medical Care Foundation

    Job Category : Academic / Research

    Job Specialty : Research Studies / Clin Trial

    Overtime Status : EXEMPT

    Primary Shift : Day

    Shift Duration : 8 hour

    Base Pay : $64,147.20 - $99,424

    Salary : $64,147 - $99,424

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