Senior Clinical Trial Associate

Department: Clinical

Employment Type: Full Time

Location: Remote

Description

Role Overview

• Support and lead the coordination of clinical trial activities across study start-up, conduct, and close-out phases.
• Assist with the preparation and review of study documents including informed consent forms, site manuals, and investigator materials.
• Drive communication and logistics with CROs, clinical vendors, and clinical sites under guidance of senior team members.
• Lead tracking and reporting of study milestones, timelines, and site performance metrics using CTMS and project management tools.
• Support clinical trial registration and disclosure posting processes.
• Participate in data review and eCRF-related activities.
• Coordinate biosample tracking and logistics including sample collection, kit preparation, and shipping schedules.
• Support invoice review and assist with vendor documentation and contract tracking.
• Participate in cross-functional study team meetings and assist with follow-up actions.
• Apply ICH/GCP knowledge to day-to-day activities; escalate compliance questions to senior staff.
• Assist with the development and maintenance of SOPs and operational process documentation.
• Provide guidance to lesser experienced CTAs as needed.  
• Perform other duties as required to support the Clinical Operations Team.

Experience & Skills and Work Environment

• Bachelor's degree or related experience required.
• 3-5+ years of experience in clinical operations required.
• Previous Biotech experience highly preferred.
• Moderate to developing knowledge of ICH/Good Clinical Practices (GCP).
• Experience with EDC systems, CTMS, or IRT systems preferred.
• Ability to apply standard practices and procedures in analyzing study data and situations.
• Strong communication and organizational skills; proficiency in Microsoft Office suite.
• Excellent attention to detail and ability to work across multiple protocols
• Ability to work independently on defined tasks and develop stable working relationships across functional teams.
• Experience in gene therapy or ophthalmology is a plus but not required.
•  Ability to manage multiple tasks and prioritize in a fast-paced environment.
• Eagerness to learn and develop professional expertise in clinical operations

• Primarily desk-based in an office or home office setting.
• May involve extended periods of sitting and computer use.
• Occasional travel may be required.

Life at Kriya

• Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
• Health & Wellness:  Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
• Financial Security: Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
• And More!