Senior Clinical Trial Associate

Accountabilities:

• Support Clinical Trial Managers and Senior Clinical Trial Managers with activities required before clinical trials begin, including clinical planning, protocol development, case report form development, IRB submissions, investigator agreements, informed consent documentation, site selection, and Trial Master File preparation.
• Coordinate with clinical trial sites regarding administrative documentation, study materials, training, and other start-up requirements.
• Support clinical operations teams in maintaining compliance with FDA and applicable international regulations, Good Clinical Practice requirements, and internal standard operating procedures throughout clinical investigations and post-market studies.
• Assist with communication and coordination with clinical trial sites regarding study conduct, monitoring activities, follow-up visits, and study closeout activities.
• Help ensure study activities and site interactions remain aligned with clinical protocols and GCP requirements.
• Assist with tracking study-related payments, invoices, and other financial or administrative documentation.
• Provide operational and workflow support to ensure departmental and cross-functional systems, processes, and procedures are completed accurately and efficiently.
• Collaborate with cross-functional project teams, including Research and Development, Regulatory, Safety, and Quality/Compliance.
• Maintain and support administrative documentation for clinical study programs, Trial Master Files, and study start-up activities.
• Assist Clinical Trial Managers and clinical operations teams with preparing and presenting clinical information related to assigned projects.
• Contribute to projects of moderate to high complexity, applying sound judgment, analytical thinking, flexibility, and problem-solving skills as required.

Requirements

• Bachelor’s degree in a health profession, life science, or related scientific discipline; an advanced degree is a plus.
• At least 3 years of clinical trial experience, with demonstrated involvement in ongoing clinical studies.
• Solid understanding of Good Clinical Practice (GCP) principles and FDA regulatory requirements.
• Knowledge of medical terminology and clinical research processes.
• Ability to work independently, manage responsibilities effectively, and exercise sound judgment in a regulated environment.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with clinical sites and cross-functional stakeholders.
• Strong organizational skills and attention to detail, particularly when managing study documentation, timelines, and administrative requirements.
• Computer proficiency, including Microsoft Word, Excel, and Outlook.
• Ability to contribute effectively within multidisciplinary project teams.
• Comfortable handling projects that require analytical thinking, flexibility, prioritization, and appropriate independent decision-making.
• Willingness to travel occasionally, as required.
• Must be authorized to work for any U.S. employer; visa sponsorship or transfer of sponsorship is not available.

Benefits

• Salary range of $85,000–$115,000, with the actual offer determined by factors such as experience, qualifications, and location.
• Eligibility for short-term and/or long-term incentive programs, where applicable.
• Medical, dental, and vision insurance.
• Disability and life insurance coverage.
• 401(k) retirement plan with company matching.
• Tuition reimbursement for select degree programs.
• Company holidays, floating holidays, paid vacation, and sick time.
• Well-being and employee support benefits.
• Fully remote work within the United States.
• Opportunity to contribute to clinical studies across the full study lifecycle.
• Cross-functional exposure to Research and Development, Regulatory, Safety, and Quality/Compliance teams.
• Professional growth opportunities within a structured clinical operations environment.