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Cynet Systems
Regulation and Start-Up SpecialistCynet Systems • Research Triangle Park, NC, United States
Regulation and Start-Up Specialist

Regulation and Start-Up Specialist

Cynet Systems • Research Triangle Park, NC, United States
3 days ago
Job type
  • Full-time
Job description

Job Title

Pay Range $22.80hr - $27.80hr

Requirements/Must Have

  • 2+ years of experience in a healthcare environment or equivalent combination of education, training and experience.
  • Strong verbal and written communication skills.

Responsibilities

  • Review documents for completeness, consistency and accuracy, under guidance of senior staff.
  • Prepare site documents, reviewing for completeness and accuracy.
  • Inform team members of completion of regulatory contractual and other documents for individual sites.
  • Distribute completed documents to sites and internal project team members.
  • Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
  • Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release.
  • Manage a team of employees responsible for executing site activation activities that may include site identification and feasibility activities, regulatory, start-up, and maintenance activities.
  • Preparation, review, negotiation and management of site regulatory documentation and clinical trial agreements with sites and sponsors.
  • Maintain, review, and report on site activation performance metrics.
  • Serve as the primary point of contact for investigative sites and/or sponsors.
  • Ensure tracking completion of all regulatory and contractual documents for sites.
  • Establish project timelines.
  • Ensure all site activation activities are performed in accordance with all regulations, SOPs, Work Instructions and project requirements.
  • Establish and/or execute goals and objectives for team(s) as well as tracking and delivering on operational/financial performance.
  • Participate in the broader Global Site Activation planning process; contribute to long-mid range goals and plans; and coordinate activities with other managers and their respective sub-families.

Education and Experience

  • Bachelor's Degree in life science or related field.
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Regulation and Start-Up Specialist • Research Triangle Park, NC, United States

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