The Specialist is responsible for user access provisioning, access coordination, compliance monitoring, and supporting clinical staff onboarding within clinical trial systems.
What We Do:
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are:
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
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.
What You'll Be Working On
Duties include but are not limited to:
Primary Duties and Essential Functions
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 offboarding.
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.
Scope of Role
Autonomy of Role: Work is performed under general supervision
Direct Reports: No
Number of Direct Reports (if applicable): N/A
Role(s) Managing: N/A
Physical Requirements
This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment.
Travel Requirements
This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
What You Bring
Knowledge, Skills, and Abilities:
-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, 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.
Benefits (US Full-Time Employees Only):
-PTO/vacation days, sick days, holidays.
-100% paid medical, dental, and vision Insurance.
-75% for dependents.
-HSA plan Short-term disability, long-term disability, and life Insurance.
-Culture of growth and equality 401k retirement plan
Diversity & Inclusion:
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Top Skills
Clinical Conductor
Edc
Emr
Florence
MS Office
Sip
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