The Specialist coordinates user access and management for clinical systems, monitors compliance, supports onboarding/offboarding, and collaborates with stakeholders to ensure study readiness and system functionality.
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.
Care Access is seeking a detail-oriented and collaborative Specialist, System User Access & SIP Management to join the Central Support Operations team within the Global Expansion and Study Operations department. This role supports critical functions that ensure clinical staff, investigators, and vendors are properly credentialed and equipped with timely and secure access to trial systems and sponsor platforms such as the Shared Investigator Platform (SIP).
The Specialist, System User Access & SIP Management is responsible for user provisioning, access coordination, documentation oversight, and vendor support related to study readiness. This position plays a key role in supporting onboarding/offboarding workflows, site activation, and identity and access management (IAM) activities that align with ICH GCP E6 (R3) standards. The ideal candidate brings experience with system access management in a regulated environment, a strong understanding of site operations, and a commitment to quality and security.
How You'll Make An ImpactThe Expertise RequiredHow We Work Together
- User Access Provisioning & Identity Management
- Create, modify, and deactivate user accounts across Care Access-contracted clinical systems and sponsor platforms (e.g., SIP).
- Manage role-based access permissions in alignment with Role-Based Access Control (RBAC) models.
- Implement and maintain secure login protocols including multi-factor authentication (MFA).
- Collaborate with IT and Care Security teams to align access policies with organizational security standards.
- Troubleshoot and resolve user access issues; request user account merges through SIP support when needed.
- Maintain complete and accurate documentation for access provisioning workflows.
- Monitoring, Compliance & Issue Resolution
- Monitor and audit user activity across platforms for ICH GCP E6 (R3) compliance.
- Troubleshoot and resolve user access issues in coordination with site staff, internal teams, sponsors, and vendors.
- Support internal and sponsor audits by providing access logs, documentation, and compliance reports as needed.
- Shared Investigator Platform (SIP) Coordination & Vendor Coordination
- Support user and facility profile management in the Shared Investigator Platform (SIP), including registrations, site assignments, and study start-up tasks.
- Assist with SIP activities such as PI changes, facility updates, staffing requests, and 1572 submissions, and coordinate with the SIP (Cognizant) team to resolve platform issues and ensure data accuracy.
- Serve as a liaison for SIP-related communications with sponsors, CRAs, and vendors to ensure accurate access and role assignments.
- Manage access and data for Care Access–contracted vendors participating in trials, including provisioning, tracking, and off-boarding.
- Site & Trial Readiness Support
- Collaborate cross-functionally to support clinical staff onboarding and offboarding workflows, ensuring timely access changes aligned with site activation timelines.
- Assist with data management of site selections and vendor alignment across new and ongoing trials.
- Provide support for clinical technologies and tools related to Protocol training, EDC, EMR, and other sponsor systems.
- General Support & Collaboration
- Collaborate with internal stakeholders to support access coordination.
- 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.
- Other Responsibilities
- 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.
- Strong understanding of system access workflows, user provisioning, and access governance within clinical research environments.
- Familiarity with platforms such as SIP, Florence (eISF), Clinical Conductor, EDC, and EMR systems.
- Knowledge of ICH GCP E6 (R3), security best practices, and regulatory documentation standards.
- Proficiency with Microsoft Office applications (Excel, Outlook, SharePoint) and database tools.
- Excellent organizational and communication skills, with the ability to support cross-functional teams and resolve access-related issues independently.
- Strong customer service orientation and professionalism in interactions with internal staff, site teams, vendors, and sponsors.
Certifications/Licenses, Education, and Experience:
- Bachelor’s degree in Health Administration, Clinical Research, Information Systems, or a related field preferred.
- Minimum of 2 years’ experience in clinical research operations, user access management, vendor coordination, or a related support function.
- Experience supporting access controls, documentation workflows, or identity management processes in a regulated environment is preferred.
- Familiarity with SIP, CTMS, and clinical trial platforms is a strong plus.
- 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]
Top Skills
Clinical Conductor
Edc
Emr
Florence
Microsoft Office (Excel
Outlook
Shared Investigator Platform
Sharepoint)
Care Access Boston, Massachusetts, USA Office
33 Arch Street, 17th Floor, Boston, MA, United States, 02110
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