Senior Clinical Trial Associate - GQR

Senior Clinical Trial Associate

Location: Waltham, MA (Hybrid, three days per week in the office)

About the Role:

This position involves assisting the Clinical Operations team in managing clinical trials, from startup to closeout, ensuring compliance with ICH, GCP, CFR, and SOP standards. Responsibilities include maintaining the Trial Master File, site management, tracking study progress, and vendor oversight. The role also supports site communication, regulatory submissions, and the preparation of study materials.

Responsibilities:

• Maintain and audit the Trial Master File (TMF).
• Assist in site communications and feasibility activities.
• Support study start-up activities, including informed consent review and document quality checks.
• Track regulatory submissions and liaise with IRBs and ethics committees.
• Prepare and distribute study-specific materials and supplies.
• Manage clinical study trackers and progress reports.
• Coordinate and participate in clinical team meetings and Investigator Meetings.
• Oversee third-party vendors involved in trials.
• Train and mentor junior Clinical Trial Associates.
• Contribute to process improvements and other departmental projects.

Qualifications:

• Bachelor’s degree in a clinical, science, or health-related field.
• Minimum of 2 years of clinical research experience in pharma, biotech, or CRO settings.
• Knowledge of FDA regulations, ICH guidelines, and GCP principles.
• Strong organizational, communication, and interpersonal skills.
• Proficiency in Microsoft Office and clinical trial management software.
• Ability to work independently, meet deadlines, and handle multiple tasks.

Benefits:

• Competitive salary with stock options.
• Fully covered health, dental, and vision insurance for employees and dependents.
• Fertility, mental health, and wellness programs.
• 401(k) with immediate company match and employee stock purchase plan.
• Generous vacation policy and company holidays.
• Short- and long-term disability, life, travel, and AD&D insurance.

This company is committed to diversity, equal opportunity, and providing reasonable accommodations for individuals with disabilities.