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Clinical Trial Manager

4 months ago

Cincinnati, United States Professional Education and Research Institute Full time
Mission Statement

PERI is an organization dedicated to promoting good quality of care in wound healing, podiatry and orthopedics through the pursuit of quality clinical research and trial management.

Goals for PERI's research mission are the following:

  • To conduct high-quality research according to the International Conference on Harmonization (ICH), Guidelines for Good Clinical Practice (GCP), National Institute of Health (NIH), Food and Drug Administration (FDA) and be in compliance with local, state and federal regulations
  • To promote and strengthen professional development of staff
  • To become recognized as an outstanding CRO for industry-sponsored clinical research
  • To advocate the value of research as a means of good quality of care in wound healing, podiatry and orthopedics
  • To provide personnel and infrastructure support for clinical research within the organization

Job Requirements

  • Education: Must have Bachelor's degree preferably in business management, biology, health sciences,
    healthcare or any related field or comparable industry experience. Preferred to have advanced degree.
  • Experience: Minimum of 4 years of clinical research experience, preferred to have 1 years of management
    experience. Must have exceptional leadership, technical and communication skills at both the site and Sponsor
    level. Ability to multitask and maintain excellent organizational skills.

Job Purpose

  • Oversee all aspects of clinical research trials ensuring protocols, contracts, GCP and applicable
    regulations are followed.
  • Direct and coordinate all clinical trial activities by employing effective organizational and communication
    skills

Duties and Responsibilities

  • Manage day-to-day operations of the study from start-up to database lockout according to
    ICH/GCP, SOPs, and all other applicable laws, rules and regulations
  • Serve as primary Sponsor and Vendor contact for operational project-specific issues and study
    deliverables
  • Provide oversight for project team and third-party vendors, ensuring all cross-functional deliverables are
    met
  • Maintain in depth knowledge of protocol, therapeutic area and indication
  • Review and provide input for studies including, but not limited to, protocol writing, inform consent
    form, edit check specifications, contracts and budgets, regulatory submission strategies, and final study
    report
  • Develop study management tools, including operational study plans and project timelines
  • Act as initial resource for study CRA's and sites with any protocol related questions
  • Provide oversight to ensure timely reporting and processing of AE's and SAE's to the Sponsor
  • Facilitate CTA negotiation and approve site payments and work closely with the Controller
  • Provide direct supervision of PERI Administrative Coordinators
  • Appropriately communicate site feedback and correspondence as applicable to the Senior Director of
    Clinical Trial Operations or the PERI Executive Committee and the Sponsor.
  • Assist with monitoring data for completeness and accuracy (via centralized or remote monitoring), onsite monitoring, and completing monitoring reports and letters for post market clinical trials.
  • Provide trial updates in a timely manner to the Sponsor and other designated individuals following
    appropriate templates, including managing team teleconference, as required.
  • Review CRA monitoring reports for completion and accuracy.

Compensation Package:

  • Starting salary rate is $100,000 to $120,000. Pay rate will be determined based on experience.

PERI Policies

Polices to be observed by all PERI employees include, but not limited to, the following:

  • PERI Standard Operating Procedures
  • PERI Employee Handbook
  • PERI Travel and Entertainment Policy