Research Quality Control Associate

JOB SUMMARY

As Research Quality Control Associate, you will be responsible for clinical monitoring activities involving Quality Control (QC) and compliance including applicable regulatory requirements and reviewing existing research projects under the direction of Research leadership.

DUTIES AND ESSENTIAL JOB FUNCTIONS:

• Conduct internal quality control activities, as an internal monitor, to ensure protocol compliance, data accuracy, and patient safety, in compliance with Sponsor protocols, Good Clinical Practices (GCPs), standard operating procedures (SOPs), and applicable agency regulations
• Report findings to QC and Research leadership and coordinate approved action items for process improvement
• Collaborate with cross-functional teams to ensure timely completion of study milestones and deliverables
• Contribute to the preparation of Quality reports and presentations for internal stakeholders
• Assist the research staff in preparation of sponsors’ audits and Food and Drug Administration inspections
• May assist with Corrective and Preventive Action (CAPA) plan resolutions as needed
• Stay current with developments in clinical research regulations, guidelines, and industry best practices
• Perform other related duties as assigned

Other Functions and Responsibilities

This job description does not cover or contain a comprehensive listing of the employee's activities, duties, or responsibilities for this job. In addition, duties, responsibilities, and activities may change at any time, with or without notice.

COMPETENCIES

1. Ethical Conduct
2. Flexibility
3. Initiative
4. Personal Effectiveness/Credibility
5. Stress Management/Composure

Requirements:

• Bachelor’s degree in life sciences or related field required
• Minimum 3 years of progressive experience in research management, monitoring, and/or quality required
• Certification in clinical research (e.g. ACRP or SOCRA) is preferred
• Valid driver’s license and insured automobile required
• Additional knowledge and skills:
  • Knowledge of research methods and procedures sufficient to compile data and prepare reports
  • Knowledge of confidentiality requirements related to patient information
  • Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements
  • Ability to learn and proficiently utilize diverse eCRF systems, electronic regulatory management systems, Electronic Medical Record systems (EMR).
  • Readiness to adapt new technology
  • Willingness to travel on-site as needed

QUALIFICATIONS:

Required

• Quality assurance/control: 4 years (Required)
• FDA regulations: 4 years (Required)