Senior Clinical Trial Associate

Kriya Therapeutics, Inc.; North Carolina; Hybrid; USD 85.000 - 110.000; Vollzeit

Benefits dieser Stelle

Flexible Time Off

Paid Parental Leave

Medical/Sick Leave

Health Insurance

401(k) with Company Match

Life Insurance

Zusammenfassung

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

You will work under light supervision, apply ICH/GCP knowledge, and help manage study activities across start-up, conduct, and close-out phases with cross-functional teams. The role emphasizes strong communication, organization, and the ability to manage multiple protocols in a fast-paced biotech environment, with opportunities to mentor

Qualifikationen

• Bachelor's degree or related experience required.
• 3–5+ years in clinical operations.
• Biotech experience preferred.
• Moderate knowledge of ICH/GCP.
• Experience with EDC/CTMS/IRT systems.
• Strong communication and organizational skills.
• Ability to manage multiple protocols and work independently.
• Gene therapy or ophthalmology experience is a plus.

Aufgaben

• Coordinate start-up, conduct, and close-out activities.
• Review study documents including informed consent forms and manuals.
• Liaise with CROs, vendors, and sites.
• Track milestones and site performance using CTMS.
• Support trial registration and disclosure posting processes.
• Participate in data review and eCRF activities.
• Coordinate biosample tracking and logistics.
• Assist with vendor contracts and invoicing.
• Participate in cross-functional study team meetings and follow-up actions.
• Apply ICH/GCP knowledge in daily activities.
• Help develop SOPs and process documentation.
• Mentor junior CTAs when needed.

Kenntnisse

Communication skills

Organizational skills

Attention to detail

Independent work

Multitasking

Ausbildung

Bachelor's degree

Tools

EDC systems

CTMS

IRT systems

Jobbeschreibung

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!