Research Quality Control Associate
3 weeks ago
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.
Pay Details: $65,000.00 to $77,000.00 per year
Search managed by: Marisa Marques
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
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