Department: Clinical
Location: Research Triangle Park, NC
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 Clinical Trials Associate supports the planning and coordination of clinical development projects under moderate supervision. This role applies developing knowledge of clinical trial processes and GCP requirements to assist in the coordination of study activities, ensuring compliance with protocols and pre-clinical objectives. The incumbent is building expertise in clinical operations and begins to contribute independently to assigned study tasks.
Key Responsibilities
- Support 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.
- Coordinate communication and logistics with CROs, clinical vendors, and clinical sites under guidance of senior team members.
- Support tracking and reporting of study milestones, timelines, and site performance metrics using CTMS and project management tools.
- Assist in clinical trial registration and disclosure posting processes.
- Participate in data review and eCRF-related activities; assist with data cleaning as needed.
- 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.
- Perform other duties as required to support the Clinical Operations Team.
Experience & Skills
- Bachelor’s degree (BS) or equivalent required.
- 1–4 years of experience in clinical research, pharma/biotech, or a related field.
- Basic to developing knowledge of ICH/Good Clinical Practices (GCP).
- Experience or exposure to 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.
- Ability to work independently on defined tasks and develop stable working relationships across functional teams.
- Experience in gene therapy or metabolic/neurologic disease 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, generally in an office or home office setting.
- Involves extended periods of sitting and computer use.
- Occasional travel may be required.
- Possibility of working outside of normal scheduled hours.
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.
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.