Care Access

QA Engineer

• Oversee the daily workflow and schedules of the department. Provide coaching and supervision to QA team, training and onboarding new staff, and ensuring team members are performing to standard of their role. Serve as the GCP lead by providing high standard of quality guidance, advice and support on GCP compliance. Manage and maintain databases for the quality systems and provide quarterly reports and quality metrics to Head of Quality Assurance. Prepare reports to track and communicate outcomes of quality assurance activities.
• Creation and tracking of the internal audit program for clinical research sites, departments, processes and vendors. Oversee and participate in its execution, peer review staff audit reports, ensuring effectiveness and compliance with regulatory requirements, company policies, and procedures. Manage, co/host and participate in preparation and execution of client audits and regulatory authority inspections.
• Collaborate with other departments and stakeholders to ensure that quality issues are addressed in a timely and effective manner. Coach and train operational staff on quality processes, including but not limited to reporting of quality issues, root cause analysis, CAPA development.
• Develop and implement policies and procedures for quality assurance activities. Review, and revision of quality assurance SOPs and procedures.
• Keep up-to-date with the latest regulatory requirements and industry best practice related to clinical research.
• International travel up to 25% as required by study requirements, staff needs, and company initiatives.

Senior Manager, Quality Assurance

Human Resources

• Translate business goals into people plans (workforce & skills), advise on org design, and drive change.
• Lead talent reviews and succession planning for critical roles; support internal mobility and engagement action-planning; lead performance management and coach managers through complex ER cases.
• Leverage AI and HRIS data to enable decisions; ensure compliance with multi-state employment laws; triage complex ER matters and partner with ER/Legal on investigations; maintain audit-ready documentation.
• Partner with Compensation on job architecture, annual pay cycles, pay-equity reviews, and offers/exceptions; collaborate with Benefits/HR Ops on leaves, accommodations, and return-to-work plans.
• Represent BU needs in HRIS/IT changes (requirements, UAT, rollout); plan people-change communications; mentor junior HR team members through coaching and skills development.

Senior HR Business Partner

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.
• 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.
• 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.
• 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.

Study Training Compliance Specialist – Delegation of Authority Matrix Management

Operations

• Project and Priority Tracking – Own the leadership priority tracker; translate team leadership priorities into tasks, owners, and dates; capture decisions and follow-ups from leadership cadences; publish weekly status notes
• Leadership Cadence, Notes, and Communication – Run end-to-end meeting operations for leadership: build and sequence agendas, pre-read packets, and briefing one-pagers; drive calendar orchestration across time zones; capture decisions and risks; send crisp action summaries within 24 hours; draft internal announcements and updates for team leadership
• Knowledge & Document Management – Maintain leadership folders, templates, and SOPs; version decks; keep a current “leadership briefing kit” (bios, org charts, current KPIs, talking points)
• Issue Triage & Stakeholder Routing – Triage inbound in Slack and email support channels; act as gatekeeper for leadership by routing requests, clarifying asks, and booking only what aligns to top priorities; log and track to closure
• Build source-of-truth slides and data for Monthly and Quarterly Business & Operational Reviews; coordinate inputs and chase owners; run version control and final QA
• Help organize logistics and track details for community events, staffing plans, and team capacity
• Assist with onboarding tasks for new full-time and temporary staff
• Vendor/partner coordination: schedule, capture next steps, and route to the right internal owner
• Facilitate organization of team-building activities, including virtual events, milestone celebrations, or wellness check-ins
• Assist with collecting feedback from the team via survey or interviews to improve operations

Community Engagement Operations Analyst

Clinical Research

• Promote awareness and education of clinical research and access to clinical trials to diverse communities
• Deliver clear, engaging presentations to individuals and groups and translate complex concepts for general audiences
• Engage with individuals and groups unfamiliar or uninterested in clinical research while maintaining respect
• Network and build partnerships, organize events, and manage on-site event coordination and logistics
• Communicate participant and partner feedback to company leadership
• Travel extensively across North America to understand and engage with diverse participants and partners
• Manage remote work and community-based responsibilities, adapting quickly to new communities
• Demonstrate empathy towards partners and participants and uphold patient confidentiality and ethical considerations
• Rapidly assimilate new information and proactively seek answers to deepen subject matter and community understanding
• Use modern technology for communication and data management and contribute to project management and problem-solving

Community Clinical Research Educator I

Manager

• The Senior Region Manager assumes overall responsibility for the management of sites assigned, including personnel management, site profitability and the successful conduct of all studies; provides leadership and oversight of site operations according to CARE SOPs, GCP and FDA/ICH Guidelines.
• What You'll Be Working On: Duties include but not limited to: Personnel; New Staff; Management of Studies and Site Workload; Quality; Financial; Site Maintenance; Community Engagement.
• Physical and Travel Requirements: travel up to 50% nationwide.
• Knowledge, Skills, and Abilities: list of capabilities.
• Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred; 2+ years management; 3+ years CRC; 2 years as CRC; 1 year as RM.
• Benefits: PTO, health insurance, HSA, disability, 401k.

Senior Region Manager-Florida

Designer

• What We Do: Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.
• 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 skilled and experienced Instructional Designer, Clinical Education to join our dynamic Clinical Education Team, part of the Global Expansion and Study Operations department.
• The Instructional Designer, Clinical Education plays a key role in designing and developing high-quality instructional materials that enhance the learning experience for clinical and operational staff. This position supports the creation of engaging, effective, and accessible learning solutions aligned with organizational goals, compliance standards, and adult learning principles.
• The ideal candidate brings a passion for education, a creative and learner-centered approach, and a strong foundation in instructional design methodologies and e-learning development—preferably within healthcare or clinical research environments.