Specialist, Study Training Compliance & DOA Management

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 to 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.

Care Access is seeking a skilled and experienced Specialist, Study Training Compliance and DOA Matrix Management, to join our dynamic Central Support Operations team, part of the Global Expansion and Study Operations department. 

The Specialist, Study Training Compliance and DOA Matrix Management within Central Support Operations team supports critical compliance functions to ensure study training requirements and delegation matrices are accurately managed across clinical research studies. This role contributes to site staff readiness and regulatory adherence by tracking training completion, maintaining essential clinical staff records, and ensuring Delegation of Authority (DOA) matrices are complete, reviewed, and approved in accordance with standard processes. 

The ideal candidate is organized, responsive, and passionate about maintaining quality in a regulated, fast-paced environment. 

• Study Training Compliance 
  • Track and monitor clinical staff training completion, including study-specific and mandatory compliance training. 
  • Support delegation processes during study start-up by verifying that training aligns with assigned roles. 
  • Ensure documentation of training is complete, current, and meets ICH-GCP, SOP, and sponsor requirements.

• Delegation of Authority (DOA) Coordination 

  • Support DOA matrix setup and maintenance by confirming training completion and role assignments. 
  • Work cross-functionally to ensure delegation readiness for protocol activities and study transitions.

• eISF & Documentation Management
  • Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems. 
  • Ensure that site staff training records are audit-ready and aligned with regulatory and sponsor expectations. 
  • Support internal audits, monitoring visits, and sponsor document requests.  

• General Support & Collaboration 
  • Collaborate with internal stakeholders to support study training and access coordination across study phases. 
  • Participate in team meetings and contribute to documentation and communication tools to enhance team efficiency. 
  • Escalate issues or delays to senior team members as appropriate to ensure study and site compliance timelines are met. 
  • Communicate effectively with internal staff, sponsors, and vendors regarding compliance tasks and timelines. 
  • Assist in problem-solving training, or access issues, contributing to solutions in collaboration with the broader team. 

•  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. 

• Understanding of clinical research operations and the importance of compliance and documentation. 
• Strong organizational and tracking skills; detail-oriented with the ability to manage multiple tasks effectively. 
• Comfortable working with technology platforms (e.g., Clinical Conductor, Florence, SIP); Microsoft Office proficiency required. 
• Strong interpersonal and communication skills for cross-functional teamwork. 
• Ability to work both independently and as part of a collaborative team. 
• Professional and adaptable when interacting with providers, vendors, and sponsor representatives. 
• Knowledgeable in Microsoft Office applications, particularly Excel, Word, Outlook, and SharePoint; familiarity with internet-based research and database systems is essential. 
• Strong interpersonal and customer service skills, with the ability to interact professionally with healthcare providers, internal staff, and external business partners. 

• Bachelor’s degree in Life Sciences, Health Administration, or a related field preferred. 
• Minimum of 2 years of experience in a Central Support or clinical research support role at Care Access or within a comparable organization (in clinical research, training compliance, operations, or document management in a regulated environment). 
• Proven experience supporting onboarding, training compliance, and/or access coordination in a regulated research environment. 
• Demonstrated ability to navigate and work within compliance-driven systems and support multi-trial documentation workflows. 
• Familiarity with eISF (Florence) and clinical training platforms is a plus. 

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.

• 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]