Kiniksa Pharmaceuticals · 14 hours ago
Clinical Trial Associate
Kiniksa Pharmaceuticals is a company focused on clinical trials, and they are seeking a Clinical Trial Associate to support the planning, execution, and delivery of clinical trials. This role involves maintaining the Trial Master File, assisting with study activities, and ensuring compliance with regulatory standards.
BiopharmaBiotechnologyMedical
Responsibilities
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
Qualification
Required
Requires a Bachelor's Degree in health or biologic science (BS/BA/ BScN or higher)
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
Preferred
Prior experience in clinical trials is preferred
Company
Kiniksa Pharmaceuticals
Kiniksa Pharmaceuticals is developing therapies for inflammatory and autoimmune conditions.
H1B Sponsorship
Kiniksa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (3)
2022 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Baker Brothers Advisors LLC
2020-05-13Post Ipo Equity· $80M
2018-05-23IPO
2018-02-01Series C· $200M
Leadership Team
Recent News
GlobeNewswire
2026-01-13
2025-12-09
2025-10-29
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