Clinical Trials GCP Quality Manager
CPC Clinical Research - Aurora, CO

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CPC Clinical Research is an academically led Contract Research Organization dedicated to the management of clinical trials with the highest levels of quality and integrity. Competitive salary and benefits package, flexible schedules, and on-site exercise facilities.

Responsibilities:

  • Direct an internal QC function to monitor and report whether clinical trial operations and deliverables are completed per contracted services and are in compliance with all local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
  • Work collaboratively with Executive Committee members to identify and implement quality control initiatives across CPC clinical trial activities to help monitor compliance with all applicable local, federal and international laws, regulations and guidelines.
  • Participate, as assigned, in the design, writing and/or QC review of project-related documents including: protocols, CRF’s, source documents, monitoring plans, study manuals, data management plans, statistical analysis plans and clinical study reports.
  • Understand and comply with all applicable regulations and relevant CPC Policies, SOPs and WIs.
  • Identify process gaps and assist in the development, review and revision of SOPs and WIs.
  • Cross-train within the organization, as needed.
  • Assist in review and tracking of site regulatory documents.
  • Directly supervise Coordinators and Assistants within the Research Operations department, including but not limited to:

o Train in all their job responsibilities
o Oversight of regulatory document tracking and maintenance of the Trial Master Files
o Comprehensive performance management

  • Maintain and distribute project documentation, including but not limited to:

o Process study related lab results, reports, letters, meeting minutes, newsletters, and regulatory documents.
o Establish and maintain central project and regulatory files, both electronic and paper.
o CTMS tracking and filing of applicable documents in the Trial Master Files

  • Provide timely feedback to supervisor on the progress of assignments.
  • Other duties as assigned.

Qualifications:

  • Bachelor’s degree preferred, but equivalent experience will be considered.
  • 4 years experience in a clinical research setting required including regulatory responsibilities.
  • Knowledge of applicable regulatory requirements (e.g. ICH, GCP and FDA) for conducting clinical trials.
  • Proficiency with Microsoft Office, particularly Word and Excel.
  • Supervisory experience preferred.
  • Excellent organizational skills, team skills, and oral and written communication skills.
  • Detail-oriented and ability to work independently.
  • Ability to work as a member of a team, establish a strong team environment for direct reports.
  • Possess good problem-solving skills, and ability to prioritize.
  • Detail oriented with exceptional organizational skills.
  • Ability to manage tasks independently and to prioritize multiple tasks.

Send cover letter, CV and 3 references.


Indeed - 17 months ago - save job - block
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