Research Quality Control Associate - LHH : Job Details

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.