Senior Clinical Research Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Specialist based in the United States.

This role plays a key part in supporting the successful execution of clinical trials across multiple stages, from start-up through close-out, within a highly regulated medical device environment. You will ensure that study documentation, regulatory submissions, and trial tracking systems are maintained with precision and compliance. Acting as a critical operational link between clinical sites, vendors, and internal teams, you will help ensure studies run smoothly, efficiently, and in alignment with global regulatory standards. The position requires strong coordination skills, attention to detail, and the ability to manage multiple studies simultaneously in a fast-paced clinical research setting. You will contribute directly to improving processes, supporting site performance, and ensuring data integrity across trials. This is a collaborative and impact-driven role within a mission-focused environment dedicated to advancing patient care through innovation.

• Manage and maintain Trial Master Files (TMF), ensuring all study documentation is accurate, up to date, and compliant with internal SOPs and regulatory requirements, while supporting inspection readiness across assigned clinical trials.
• Track and monitor study progress across multiple systems, including essential documents, investigational products, trial supplies, and subject visit milestones, ensuring visibility and operational control.
• Coordinate regulatory submissions and support IRB/EC processes, including document preparation, review, follow-ups, and resolution of compliance gaps with clinical sites and vendors.
• Provide operational and administrative support to clinical study teams, including meeting coordination, agendas, minutes, training documentation, and cross-functional communication.
• Support clinical site interactions by assisting with enrollment tracking, site communications, issue resolution, and clinical supply or documentation needs.
• Contribute to study start-up, execution, and close-out activities, ensuring adherence to timelines, GCP standards, and clinical operational plans.

Requirements:

• Bachelor’s degree in a scientific discipline, nursing, or related field, combined with at least 6 years of clinical research or clinical trial operations experience.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and US clinical research regulations, with demonstrated ability to apply compliance standards in daily work.
• Experience in clinical trial coordination, preferably within medical device or similarly regulated environments.
• Excellent organizational and multitasking skills, with the ability to manage multiple studies, deadlines, and documentation requirements simultaneously.
• Strong written and verbal communication skills, with the ability to collaborate effectively across clinical sites, vendors, and internal teams.
• Proficiency with clinical systems and standard office tools (spreadsheets, databases, document management systems).
• High attention to detail, analytical mindset, and strong problem-solving abilities in a regulated environment.

Benefits:

• Competitive compensation aligned with experience and industry standards
• Fully remote work model within the United States
• Comprehensive health, dental, and vision insurance (eligible shortly after hire)
• Paid time off including vacation, sick leave, and company holidays
• 401(k) retirement plan with employer participation
• Health savings account (HSA) and flexible spending account options
• Strong emphasis on work-life balance and employee wellbeing
• Opportunities for professional development in clinical research and regulatory operations
• Exposure to global clinical trials in a leading medical device environment