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Care Access

Manager, Study Training Compliance & DOA Matrix Management, Central Support Operations

Posted 3 Days Ago
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Remote
Hiring Remotely in United States
Senior level
Remote
Hiring Remotely in United States
Senior level
Oversee study training compliance and DOA matrix management, ensuring regulatory alignment and operational excellence. Lead a high-performing team to optimize processes and prepare for audits.
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About Care Access

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

To learn more about Care Access, visit www.CareAccess.com.

 
How This Role Makes a Difference

Care Access is seeking an experienced and strategic Manager, Study Training Compliance and DOA Management to lead a high-performing team within the Central Support Operations unit, part of the Global Expansion and Study Operations department. 

This role is responsible for overseeing the development, execution, and continuous improvement of study training compliance and Delegation of Authority (DOA) matrix management processes across the organization’s clinical research portfolio. The Manager ensures all activities align with regulatory standards, sponsor expectations, and internal quality systems, contributing to overall site and study readiness. 

As a departmental leader, this individual will supervise a team of specialists and senior specialists, manage workload prioritization, support audit preparedness, and drive operational excellence through strategic collaboration and cross-functional partnership. The ideal candidate brings deep clinical research experience, a proactive mindset, and a strong track record in managing documentation-driven compliance operations in regulated environments. 

How You'll Make An Impact
  • Team Leadership & Oversight 
    • Supervise, mentor, and develop a team of specialists and senior specialists supporting study training compliance and DOA matrix functions. 
    • Manage daily team operations including task delegation, performance tracking, workload balancing, and professional development support. 
    • Establish team goals, timelines, and KPIs aligned with departmental and organizational priorities. 
    • Ensure team adherence to SOPs, training protocols, and documentation standards. 
  • Training Compliance Strategy & Oversight 
    • Oversee organization-wide monitoring of clinical staff training completion for both study-specific and mandatory compliance training. 
    • Ensure standardization of training tracking workflows, documentation accuracy, and timely resolution of gaps across trials. 
    • Collaborate with internal clinical education team, compliance, and operations teams to align on training expectations and rollout strategies.
  • Delegation of Authority (DOA) Matrix Management 
    • Own the process for DOA matrix setup, maintenance, review, and investigator approvals across trials. 
    • Ensure delegation alignment with role-based training completion, protocol requirements, and site activation timelines. 
    • Serve as a subject matter expert on DOA matrix processes during audits, inspections, and sponsor inquiries.  
  • Audit & Inspection Readiness 
    • Partner with Clinical Operations, Quality, Clinical Education, and other internal stakeholders to ensure training and delegation matrix readiness across study lifecycles. 
    • Support site-staff and study start-up readiness by contributing to training plans, documentation checklists, and process guidance. 
    • Represent the function in planning meetings, trial kick-offs, and sponsor-facing communications when required. 
    • Develop and refine audit preparedness strategies across Central Support Operations. 
  • Process Optimization & Strategic Projects 
    • Identify gaps, inefficiencies, and risks in current workflows; lead improvement initiatives to increase compliance, efficiency, and documentation integrity. 
    • Contribute to the development and refinement of SOPs, Work Instructions, system design, and quality tools to support scale and consistency across programs. 
    • Monitor performance metrics and provide insights to leadership to support continuous improvement.  
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.  
The Expertise Required
  • Deep understanding of clinical research operations, GCP compliance, and site readiness requirements. 
  • Strong leadership and team development skills, with the ability to guide staff through complex compliance and operational workflows. 
  • Advanced skills in documentation management, audit preparation, and protocol compliance tracking. 
  • Proficiency with systems such as Florence (eISF), Clinical Conductor (CTMS), and sponsor-facing training platforms. 
  • Excellent interpersonal and communication skills, including the ability to interact professionally with clinical teams, sponsors, and leadership. 
  • Strong analytical and organizational abilities with attention to documentation accuracy, timelines, and regulatory requirements. 
  • Proficient in Microsoft Office Suite and collaborative tools (Excel, SharePoint, Outlook, etc.). 
Certifications/Licenses, Education, and Experience:
  • Bachelor’s degree in Life Sciences, Health Administration, Clinical Research, or a related field required; Master’s degree or certification (e.g., ACRP, SOCRA) preferred. 
  • Minimum of 5+ years of experience in clinical research or regulatory compliance, including at least 2 years in a team lead or management role. 
  • Demonstrated success in managing training compliance, DOA matrix workflows, and documentation oversight within a regulated clinical trial environment. 
  • Experience supporting audits, inspection readiness, and cross-functional collaboration in a multi-study organization. 
How We Work Together
  • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
  • Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Benefits & Perks
  • Paid Time Off (PTO) and Company Paid Holidays
  • 100% Employer paid medical, dental, and vision insurance plan options
  • Health Savings Account and Flexible Spending Accounts
  • Bi-weekly HSA employer contribution
  • Company paid Short-Term Disability and Long-Term Disability
  • 401(k) Retirement Plan, with Company Match 

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. 

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: [email protected]


Top Skills

Clinical Conductor Ctms
Excel
Florence Eisf
Microsoft Office Suite
Outlook
Sharepoint

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