Clinical Trial Associate

Reporting to the VP of Clinical Operations or delegate, the Clinical Trial Associate (CTA) will support the planning, execution and delivery of clinical trials in accordance with Kiniksa SOPs, ICH/GCP and applicable regulatory requirements, timelines, budget, and quality standards. This role will partner closely with the Clinical Operations study management team to ensure efficient study management.

This role is office based in Lexington, Ma, 4-5 days per week.

Responsibilities (including, but not limited to):

* Maintain and organize the Trial Master File (TMF), ensuring completeness, accuracy and timeliness, and assist the study team with filing to the TMF

* Support collection, management and tracking of clinical trial plans and other study documents, timelines, and milestones

* Assist with study start-up, maintenance and close out activities as directed by the study management team

* Support meeting logistics, agenda, minute-taking, and tracking of decisions and actions

* Assist with vendor communications and follow-up on operational requests

* Collaborate with the cross-functional team as agreed with the clinical operations study management team

* Support inspection readiness activities

* Ensure trial conduct aligns with ICH-GCP, SOPs, applicable regulations, and study plans / manuals

* Maintain study trackers, dashboards, and logs for decision, action and risks

* Track budgets, invoices, and forecast updates under supervision

* Escalate risks, issues, or inconsistencies to the study management team

* Support continuous improvement of study processes and documentation practices

Qualifications:

* Requires a Bachelor's Degree in health or biologic science (BS/BA/ BScN or higher)

* Prior experience in clinical trials is preferred

* Strong attention to detail with excellent organization skills

* Effective written and verbal communication skills

* Proficient with Microsoft Office; familiarity with clinical systems (eTMF, CTMS) is a plus

* Ability to work collaboratively in a fast-paced, team-oriented environment.

* Salary is commensurate with experience

* Kiniksa Benefits Summary - USA

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.