Senior Internal Clinical Research Associate

About the role

This position supports the Clinical Research team, focusing on trial conduct and site management activities in the U.S. following good clinical practice and all applicable regulations. You will collaborate with external Contract Research Organizations, vendors, field Clinical Research Associates, study teams, customers, and internal partners to enable patient access to advanced care for venous thromboembolism.

Responsibilities

• Lead operational execution of assigned clinical studies while ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Serve as a key liaison between internal study teams, field Clinical Research Associates (CRAs), clinical sites, vendors, and external partners to facilitate successful study execution.
• Support the development, review, and maintenance of study documentation, including protocols, informed consent forms, monitoring plans, case report forms, and study-related materials.
• Oversee Trial Master File (TMF) activities to ensure accuracy, completeness, and inspection readiness.
• Develop and maintain study dashboards, trackers, metrics, and reports to support study oversight and decision-making.
• Monitor site performance metrics and collaborate with study teams to proactively identify and resolve operational challenges.
• Support study budget tracking, site payments, vendor invoicing, and financial reconciliation activities.
• Partner cross-functionally with Clinical Program Management, Data Management, Regulatory Affairs, Quality, and Medical Affairs teams to support study objectives.
• Contribute to audit and inspection readiness activities and support responses to regulatory requests.
• Mentor and provide guidance to junior team members while supporting process improvement initiatives that drive operational excellence.

Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related scientific discipline.
• Minimum of 2+ years of clinical research experience, preferably within a medical device, biotechnology, pharmaceutical, CRO, or sponsor environment.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical research processes.
• Experience supporting clinical study operations, study documentation, and trial execution activities.
• Strong organizational, communication, and project management skills.
• Demonstrated ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience supporting U.S. and/or global medical device clinical studies.
• Experience with clinical systems including CTMS, EDC, eTMF, and other clinical trial platforms.
• Experience with study metrics, dashboards, site management, and operational reporting.
• Experience supporting study budgets, site payments, contracts, vendor management, or financial tracking activities.
• Experience supporting audits, inspections, regulatory submissions, or inspection-readiness activities.
• Clinical research certification (SOCRA, ACRP, CCRP, CCRC, or equivalent).
• Experience mentoring, training, or guiding junior team members.

Pay

• USN: $83,300 - $138,800 USD Annual
• US5: $87,500 - $145,700 USD Annual
• US10: $91,600 - $152,700 USD Annual
• US15: $95,800 - $159,600 USD Annual
• US20: $100,000 - $166,600 USD Annual
• US30: $108,300 - $180,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.