Quality Specialist

Description

ObjectiveHealth is seeking a Quality Specialist to support our mission of advancing clinical research at the point of care. In this role, you’ll help ensure the accuracy, compliance, and integrity of our clinical trials through real-time quality reviews and cross-functional collaboration. Join us in driving innovation and excellence in clinical research.

Who We Are

ObjectiveHealth is a clinical research company that uses proprietary technology to:

• Increase patient access to research trials within our communities,
• Provide physicians with enhanced care options for current patients, and
• Deliver superior clinical research enrollment metrics to Pharma sponsors
  
  

All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.

Key Responsibilities

• Conduct real-time, ongoing quality control reviews across all components of clinical research and document findings in a timely and accurate manner.
• Audit all clinical trial documentation for accuracy, completeness, and compliance with applicable regulations and internal standards.
• Ensure study procedures are conducted and documented in accordance with the approved protocol, Good Clinical Practice (GCP), and ObjectiveHealth policies.
• Collaborate cross-functionally with clinical, regulatory, and operations teams to address quality deficiencies and drive continuous improvement.
• Monitor adherence to ObjectiveHealth controlled documents (SOPs, policies, and work instructions) across relevant departments.
• Assist in the evaluation, revision, and improvement of ObjectiveHealth controlled documents in coordination with the broader Quality team.
• Provide feedback and support during internal and external audits or inspections as needed.
• Perform other related duties and responsibilities as assigned by management.
  
  

Qualifications

• Minimum of 2 years of experience in clinical research, quality assurance, or a similar regulatory environment.
• Strong knowledge of GCP, FDA regulations, and ICH guidelines.
• Excellent attention to detail and analytical skills.
• Strong interpersonal and communication skills; able to work both independently and collaboratively.
• Proficiency in Microsoft Office Suite and experience with clinical trial management systems (CTMS) is a plus.
  
  

What We Offer

Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.

Requirements

This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

Salary Description

$66,000 - $74,000

ObjectiveHealth is a clinical research company that uses proprietary technology to increase patient access to research trials within our communities, provide physicians with enhanced care options for current patients, and deliver superior clinical research enrollment metrics to Pharma sponsors with the goal of Improving Patient Outcomes at the Point of Care.