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Clinical Operations Lead II

Florida Cancer Specialists and Research Institute

Saint Petersburg, Florida
Job Status:
Full Time
  • Clinical Operations
Florida Cancer Specialists and Research Institute
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Job Details

Position Overview

The Clinical Operations Lead II (COL II) will be responsible for performing activities that will provide oversight of vendors and United Therapeutics staff responsible for conducting clinical trial activities. This individual will be responsible for compiling and reporting quality metrics, conducting risk assessments of protocols and processes, managing Clinical Operations CAPAs, building effective relationships with internal and external customers and ensuring continuous improvement in the conduct of clinical trial activities.

Key Accountabilities / Responsibilities

  • Develop and implement the Clinical Operations Quality Management Plans (QMP’s) including the oversight of vendors and contractors assigned to regional or global UT studies
  • Management of ongoing data review pertinent to the QMP
  • Collaborate with Clinical Operations study teams to identify risk in protocols and processes
  • Develop reports that highlight concerns and outline action plans
  • Collect and analyze qualitative and quantitative results from oversight visits
  • Communicate concerns arising from oversight visits to appropriate clinical staff
  • Address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified
  • Provide on-site training for monitors and site staff as needed
  • Assist in the development and presentation of continuing education based on findings from oversight visits
  • Conduct QC assessments to verify selected study documents are complete and correct
  • Manage Clinical Operation CAPAs from initiation to closure
  • Collaborate with GCP Compliance/QA to identify trends resulting from GCP Compliance/QA audits
  • Identify areas for process improvement
  • Support clinical team in preparing for external audits
  • Support clinical team by providing input into the generation of timely and appropriate audit responses
  • Maintain strong working knowledge of SOP’s
  • Maintain strong working knowledge of ICH-GCP, regulatory requirements and guidelines
  • Provide staff support by being a contact point for information and advice relating to ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
  • Responsible for the provision and delivery of training concerning ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
  • Design, develop and implement clinical training programs within Global Clinical departments
  • Qualify new hire monitors to perform assigned functions independently
  • Ensure clinical staff stay knowledgeable of relevant UT-SOP’s, ICH, GCP, local regulations and guidelines
  • Address training needs identified by Clinical Operations oversight and Global Compliance/QA activities
  • All other duties as required 

Minimum Requirements

  • Bachelor’s degree required; scientific related field preferred
  • 10+ years in the biopharmaceutical research & development or in a CRO
  • 8+ years as a CRA and/or Clinical Manager in the biopharmaceutical industry
  • Experience with developing SOPs and department processes, including the requirements for and interpretation of Clinical SOP’s
  • Experience with training and mentoring clinical research staff
  • Strong working knowledge of US FDA, EU and GCP and local regulations
  • Solid understanding of the clinical research process, regulations pertaining to good clinical practice, and the function of quality control in the conduct of clinical studies
  • 30% travel required to various locations as directed

Preferred Knowledge, Skills, and Abilities

  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Proficient in EDC and CTMS systems
  • Prior experience with quality assurance audits
  • Strong interpersonal and written/oral communication skills to facilitate interaction with internal and external customers
  • Ability to work independently with occasional oversight
  • Ability to work effectively and diplomatically with supervisors, peers, and support personnel both internal and external to the organization.
  • Strong time management and organizational skills
  • Attention to detail and accuracy in work
  • Ability to multitask and prioritize in a rapidly moving environment
  • Ability to lead teams and projects in a matrix environment
  • Must be detail oriented, self motivated, organized and have the ability to prioritize work
  • Must be able to work independently and as part of a multi-functional team

United Therapeutics  Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities


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