Senior Clinical Trial Associate

Kriya Therapeutics, Inc.

United States

Remote

USD 65,000 - 90,000

Full time

4 days ago
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Benefits offered by this job

Flexible Time Off
Medical, Dental, Vision Insurance
401(k) with Company Match
Employee Assistance Program

Job summary

Kriya Therapeutics, Inc. is seeking a Senior Clinical Trial Associate to support planning and coordination of clinical development projects in a remote capacity.

The role applies evolving knowledge of clinical trial processes and GCP to ensure protocol compliance and contributes independently to study tasks. Responsibilities include coordinating start-up, conduct, and close-out phases; preparing study documents; liaising with CROs, vendors, and sites; tracking milestones with CTMS; data review;

Qualifications

  • Bachelor's degree required or related experience.
  • 3–5+ years in clinical operations preferred.
  • Biotech experience highly preferred.

Responsibilities

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

Skills

Project coordination
ICH/GCP knowledge
EDC/CTMS/IRT experience
Strong communication
Microsoft Office proficiency

Education

Bachelor's degree or related experience

Tools

EDC systems
CTMS
IRT systems

Job description

Senior Clinical Trial Associate

Department: Clinical


Employment Type: Full Time


Location: Remote



Description

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.


We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.


We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”



Role Overview

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; escalated 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


  • 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.



Life at Kriya

Discover True Collaborative Teamwork

We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.


We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.



Rewards & 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!

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