MERIT CRO

QA Engineer

• Review software test cases and test runs for both customized and COTS software, including automated and manual testing
• Support and review validation deliverables such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), traceability matrix, and summary reports
• Support and review project software development life cycle (SDLC) with company SOPs and risk management processes; review risk management plans and reports
• Ensure Software Requirement Specifications (SRS) are adequately tested following a risk-based approach per GAMP5 and FDA CSV guidelines
• Understand EXCELSIOR™ product and conduct of clinical trials to discuss tasks with cross-functional teams
• Assist with vendor and external contractor qualification, audits, and maintenance activities
• Assist in development, review, and administration of user manuals, policies, training, and SOPs; provide training for internal and regulatory requirements
• Ensure SOPs are followed in daily operations including CAPA, deviations, non-conformances, document control, change control, validations, and training
• Generate regular and ad-hoc reports to support project progress and provide updates to internal stakeholders
• Develop and maintain awareness of industry standards and best practices and promote quality and continuous improvement

Software Quality Assurance Specialist

Business Development Rep

• Cultivates and expands strategic relationships with pharma, biotech, and CROs in the respiratory space
• Develops and maintains a positive Company image and relations with integrity between the Company and key customers
• Identify, develop, and grow referral and client relationships within hospitals, physician clinics, research organizations, and service areas
• Conduct introductory calls, presentations, and educational sessions to showcase products, services, and research capabilities
• Generate leads, manage sales pipelines, and convert opportunities into long-term business
• Deliver responsive and attentive customer service to ensure satisfaction and retention
• Collaborate with internal teams to ensure seamless onboarding and account support
• Prepare and submit sales reports, maintain CRM data, and track market/territory trends
• Participate in promotional activities such as trade shows, conferences, seminars, and client events
• Organize and prioritize work assignments; apply creative problem solving; maintain professional and compliant conduct

Respiratory Accounts Business Development Specialist, Sales Focused

Project Manager

• Support execution of respiratory-focused clinical trials under guidance of Senior Project Manager.
• Assist with study start-up activities, preparation of study materials, organization of kick-off meetings, and documentation.
• Support routine communication with sponsors, sites, and internal teams, escalating issues to Senior PM as appropriate.
• Contribute to development and maintenance of study-specific documentation including Master Project Files, site lists, correspondence logs.
• Generate and distribute status reports, eligibility reports, and study notifications; attend sponsor, investigator, and internal meetings.
• Perform initial reviews of spirometry and PFT data submitted by sites; assist with data queries, clarifications, issue resolution with Respiratory therapist and Senior PM.
• Conduct quality control checks of clinical data to support audit readiness and data integrity; document findings and contribute to corrective action processes.
• Gain working knowledge of EXCELSIOR™ platform; assist with configuration, user acceptance testing, study-specific documentation, site setup, and support.
• Monitor user access, respond to support tickets, escalate technical issues, follow up with sites, sponsors, reading center personnel on EXCELSIOR access.
• Participate in professional development; comply with company policies and SOPs; ability to travel up to 5%.

Respiratory Project Manager I

Procurement

• Draft, review, and manage contracts in collaboration with legal and business teams.
• Maintain and update contract templates and standard clauses.
• Ensure contracts comply with internal policies and applicable laws and regulations.
• Track contract milestones, expirations, and renewal dates.
• Coordinate contract approvals and signatures using electronic systems.
• Serve as the primary point of contact for contract-related inquiries.
• Collaborate with cross-functional teams to ensure contract terms align with operational needs.
• Maintain accurate and organized contract records in the contract management system.
• Assist in resolving contract disputes or issues in coordination with legal counsel.
• Support audits and reporting requirements related to contracts.
• Monitor contract compliance and identify potential risks or deviations.
• Recommend improvements to contract processes and risk mitigation strategies.
• Ensure confidentiality and proper handling of sensitive contractual information.
• Comply fully with company policies and Standard Operating Procedures (SOPs).

Software Quality Assurance Specialist

Respiratory Accounts Business Development Specialist, Sales Focused

Respiratory Project Manager I

Contract Management Specialist