Senior Clinical Trial Associate

Kriya Therapeutics•Remote, NC

2d•Remote

About The Position

The Senior Clinical Trial Associate supports the planning and coordination of clinical development projects under light supervision. The role applies developing knowledge of clinical trial processes and GCP requirements to coordinate study activities and help ensure compliance with protocols. Building on prior clinical operations expertise, the associate contributes independently to assigned study tasks and may provide guidance to less experienced CTAs. The position supports clinical studies throughout start-up, conduct, and close-out, including study documentation, communications with CROs, vendors, and sites, milestone tracking, registration and disclosure, data review, biosample logistics, invoices, and operational documentation. The role participates in cross-functional study team meetings and escalates compliance questions to senior staff. The role is remote and primarily desk-based in an office or home office setting, with extended periods of sitting and computer use. Occasional travel may be required.

Requirements

Bachelor's degree or related experience required.
3–5+ years of experience in clinical operations required.
Moderate to developing knowledge of ICH/Good Clinical Practices (GCP).
Ability to apply standard practices and procedures when analyzing study data and situations.
Strong communication and organizational skills.
Proficiency in the 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.
Ability to manage multiple tasks and prioritize in a fast-paced environment.
Eagerness to learn and develop professional expertise in clinical operations.

Nice To Haves

Previous biotech experience highly preferred.
Experience with EDC, CTMS, or IRT systems preferred.
Experience in gene therapy or ophthalmology is a plus but not required.

Responsibilities

Support and lead coordination of clinical trial activities across study start-up, conduct, and close-out phases.
Assist with preparing and reviewing study documents, including informed consent forms, site manuals, and investigator materials.
Drive communication and logistics with CROs, clinical vendors, and clinical sites under guidance from 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 and escalate compliance questions to senior staff.
Assist with developing and maintaining SOPs and operational process documentation.
Provide guidance to less experienced CTAs as needed.
Perform other duties as required to support the Clinical Operations Team.