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Research Quality Control Associate

LHH
Indianapolis, IN Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/2/2025

Job Title : Research Quality Control Associate

Type : Direct Hire

Location : Indianapolis, IN

Hybrid (Ideal)- Initially, more onsite presence is required, but long-term, 2 days onsite per week.

Must be located in Indiana, preferably Indianapolis.

Hours : M-F 8-5

Pay : $65,000-74,000 (8% bonus target)

Job Overview : A leading healthcare organization is seeking a meticulous and experienced Research Quality Control Associate to join their team. This role is essential in ensuring the quality and compliance of clinical research activities. The ideal candidate will have a strong background in research management, monitoring, and quality control, with a commitment to maintaining high standards in clinical research.

Key Responsibilities :

  • Conduct internal quality control activities to ensure protocol compliance, data accuracy, and patient safety in accordance with sponsor protocols, Good Clinical Practices (GCPs), standard operating procedures (SOPs), and applicable regulations.
  • Report findings to Quality Control and Research leadership, coordinating 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 research staff in preparing for sponsor audits and FDA 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.
  • Audits and site visits are required.

Qualifications :

  • Bachelor's degree in life sciences or a related field is required.
  • Minimum of 3 years of progressive experience in research management, monitoring, and / or quality control.
  • Certification in clinical research (e.g., ACRP or SOCRA) is preferred.
  • Experience working with pharmaceutical-sponsored studies is preferred.
  • Valid driver's license and insured automobile required.
  • Proficiency in electronic Case Report Form (eCRF) systems, electronic regulatory management systems, and Electronic Medical Record (EMR) systems.
  • Willingness to travel on-site as needed.
  • Benefits :

  • Competitive salary and benefits package.
  • Opportunity to work with a leading healthcare organization dedicated to improving patient care through innovative research.
  • Collaborative and supportive work environment.
  • Salary : $65,000 - $74,000

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