[Hiring] Senior Clinical Trial Associate @Kriya Therapeutics

Role Description

The Senior Clinical Trial Associate supports the planning and coordination of clinical development projects under light supervision. This role applies developing knowledge of clinical trial processes and GCP requirements to support in the coordination of study activities, ensuring compliance with protocols. The Senior Clinical Trial Associate is building on prior expertise in clinical operations and contributes independently to assigned study tasks.

Key Responsibilities

• 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.

Qualifications

• 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.

Work Environment

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

Benefits

• 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!