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.