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    Director of Clinical Research Operations - Summerville, United States - Articularis Healthcare

    Articularis Healthcare
    Articularis Healthcare Summerville, United States

    6 days ago

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    Description

    Job Description

    Job DescriptionSalary:

    Articularis Healthcare Group (AHG) is currently seeking a full-time Director of Clinical Research Operations.

    Our Benefits:

    Dynamic work environment and work week.

    Benefits package that includes group medical, dental, vision, short-term & long-term disability insurance, paid holidays, PTO and 401K.

    Our Company:

    Articularis Healthcare Group is a physician led and owned organization dedicated to improving healthcare by supporting independent rheumatology practices across the country. As the nation's largest rheumatology specialty group with 20+ practices across 7+ states, AHG provides access to best business practices, advisory and management services, and value-based treatment pathways. Please visit our website at for more information.

    Our Mission:

    Delivering the highest quality community-based rheumatology services with a commitment to patient care, physician leadership and excellence.

    The Position:

    The Director of Clinical Research Operations is responsible for overseeing the organization, financial viability, and leadership of Articularis Healthcare Group (AHG) clinical research programs.

    Essential Responsibilities:


    • Designs and executes a portfolio of clinical research studies that are meant to measure the efficacy of products or protocols that are expected to serve a medical need.

    • Adheres to GCP and FDA guidelines when implementing research trials to ensure highest quality research.


    • Designs timelines, budgets, and contingency/risk management plans to ensure successful execution of clinical trials.


    • Actively seeks opportunities to improve financial outcomes, engaging staff in the process.


    • Reviews research specifications and assigns resources accordingly.


    • Reviews and analyzes research data to ensure all clinical data meets all necessary regulatory standards across AHG.


    • Screens patients record for identification of prospective candidates for research protocols, in tandem with the Primary Investigator (PI) and CCRC.


    • Creates and implements standard operating procedures as it pertains to research and research studies.


    • Guides and directs Clinical Research teams across AHG, and provides valuable insight and mentorship.


    •Monitors research activity to ensure compliance with Standard Operating Procedures and Good Clinical Practices.


    • Establishes annual financial goals and actively uses benchmarking to high performing systems in similar area of expertise to set annual targets.


    • Monitors and analyzes financial data and utilizes for decisions regarding FTE's, staffing and operational budget.


    • Establishes an annual operating and capital budget, demonstrating fiscal responsibility through meeting budget targets.


    • Reviews and negotiates contracts with existing and potential clinical research sponsors.


    • Allocates resources to clinical research projects by assigning staff to clinical studies that are appropriate based on their experience and training.


    • Schedules and attends Investigator meetings.


    • Contributes to the analysis and interpretation of clinical research data.
    Maintain records related to operations and services that are complete, accurate, available, and in compliance with all legal, regulatory, and policy require

    • Keeps abreast of current data, trends, regulations, developments, and advances in area of expertise.
    Engages staff and other stakeholders in continuous improvement of systems and processes; manages resources for staff participation in improvement work activities.

    • Ensures effective facilitation of improvement teams and development of leadership skills to ensure overall effectiveness of the meetings.


    • Performing other duties as needed.

    This job might be for you if:


    • You have a Bachelor's degree. (medical/clinical setting preferred).

    • You have a minimum 5 years of related leadership experience.

    • You have prior management experience in a medical/clinical environment.

    • You have practical experience with the concepts and principles of clinical
    research programs.

    • You have previous experience with strategic planning, direction, and goal setting
    for a department.

    • You have project management experience in a research environment.

    • You have strong knowledge of industry standards and/or regulatory requirements.

    • You are Knowledgeable about insurance billing, and the Medicare Coverage Act..

    • You have excellent written, verbal, interpersonal, and presentation skills.

    Why you should apply:

    Joining our AHG team will provide you with a positive team environment, growth and advancement opportunities, as well as a work/life balance.

    Next Steps:

    Once you submit your application, a member of our Talent Acquisition Team will review your resume and application. A team member will reach out to you within a week to schedule a phone screening.

    EEO/AA-M/F/disabled/protected veteran

    *Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

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