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Regulatory Affairs Manager in Clinical Research

2 months ago


Phoenix, Arizona, United States DocTrials Full time
Position Overview

DocTrials is in search of a skilled Clinical Research Regulatory Manager. This role is ideal for individuals who have a strong commitment to regulatory adherence, effective task management, and the maintenance of excellence in clinical research. As a vital contributor to our organization, you will be responsible for supervising various regulatory functions and ensuring that all procedures comply with industry standards.

Core Responsibilities:

  • Lead the organization-wide Regulatory Compliance initiatives
  • Oversee tasks within the Regulatory Department
  • Facilitate Credentialing Processes
  • Manage Calibration & Certification activities
  • Direct Study Start-Up Procedures
  • Perform Internal Monitoring & Mock Audits
  • Administer Audit Management processes
  • Develop & Maintain Standard Operating Procedures (SOPs)
  • Evaluate & Sanction Protocol Deviations
  • Foster Sponsor/CRO Relationships
  • Coordinate Study Meetings
  • Supervise Monitor Visits
  • Manage Study Close-Out Procedures

Required Qualifications:

  • Expertise in Clinical Trial Management Systems (CTMS) and related clinical research tools
  • Excellent organizational and communication abilities
  • Knowledge of ICH-GCP and FDA regulations
  • Capability to handle multiple tasks and meet deadlines efficiently
  • Background in clinical research management

What We Provide:

  • Attractive Salary Package
  • Comprehensive Benefits
  • Paid Time Off
  • Incentive Structure
  • Opportunities for Professional Growth
  • Collaborative Work Environment

About DocTrials:

At DocTrials, we are dedicated to executing high-quality clinical studies across a network of physician sites. Our mission is to connect patients and healthcare providers with innovative therapies, offering hope and new treatment possibilities. Be part of our effort to make a significant impact in the healthcare sector.