Director of Clinical Research Operations at Articularis Healthcare
Summerville, SC 29486, USA -
Full Time


Start Date

Immediate

Expiry Date

14 Jun, 25

Salary

0.0

Posted On

14 Mar, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Insurance Billing, Regulatory Requirements, Strategic Planning

Industry

Pharmaceuticals

Description

Articularis Healthcare Group (AHG) is currently seeking a full-time Director of Clinical Research Operations based out of Summerville, SC. This position is remote eligible with application travel.
Who We Are:
Articularis Healthcare Group, Inc. (AHG) is an independent physician-led, clinically integrated, group of medical professionals who use the latest clinical innovations to provide compassionate and exceptional patient care. We are committed to helping patients, people, and medical practices thrive.

What Sets Us Apart:

  • We are physician-led.
  • We make decisions together.
  • We’re independent by design.

Our Mission:
Delivering the highest quality community-based rheumatology services with a commitment to patient care, physician leadership and excellence. Our core values are Compassion, Integrity, Quality, Respect and Teamwork.
Visit www.articularishealthcare.com to learn more about us!
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 SOPs 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.
  • Schedules and attends Investigator meetings.
  • 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.
  • Performing other duties as needed.

Minimum qualifications:

  • Related Bachelor’s degree.
  • 5+ years of related leadership experience.
  • Prior management experience in a medical/clinical environment.
  • Practical experience with clinical research programs.
  • Experience in strategic planning, direction, and goal setting for a department.
  • Research project management experience.
  • Strong knowledge of industry standards and/or regulatory requirements.
  • Knowledge about insurance billing, and the Medicare Coverage Act..
  • Excellent written, verbal, interpersonal, and presentation skills.

Next Steps:
Once you submit your application, a member of our Talent Acquisition Team will review your resume and application.

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

  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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 SOPs 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.
  • Schedules and attends Investigator meetings.
  • 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.
  • Performing other duties as needed
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