Clinical Trial Operations Specialist

2 days ago

Lexington, Massachusetts, United States Kiniksa Pharmaceuticals Full time
Job Summary

We are seeking a highly skilled and experienced Clinical Trial Associate to join our team at Kiniksa Pharmaceuticals. As a key member of our Clinical Operations department, you will be responsible for the daily administrative aspects of clinical trials, from planning to execution, ensuring compliance with regulatory guidelines and ICH/GCP standards.

Key Responsibilities
  • Manage study-related vendors and serve as a point of contact for contracted CROs, study staff, and contract labs, identifying potential risks and proactively resolving issues.
  • Review monitoring reports, protocol deviations, and data listings for studies, ensuring accuracy and compliance.
  • Coordinate cross-functional project-related activities, such as Clinical Data Review meetings, to ensure seamless execution.
  • Collaborate with CROs on site selection, IRB submissions, site initiation, and close-out planning, ensuring timely and efficient execution.
  • Develop and lead the development of reports for communicating study progress and key metrics to Senior Management and program teams.
  • Perform initial review of invoices against contracted services, ensuring accuracy and compliance.
  • Assist with budget management, ensuring effective resource allocation and financial planning.
  • Prepare and provide input to study timelines, ensuring realistic and achievable goals.
  • Develop and manage study trackers, providing metrics as needed to support informed decision-making.
  • Perform and/or oversee site monitoring visits for clinical trials as needed, ensuring compliance and quality.
  • Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections, ensuring compliance and quality.
  • Ensure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocols, ensuring accuracy and compliance.
Requirements
  • Requires a Bachelor's degree with at least 3 years of relevant work experience in a pharmaceutical, academic, or CRO environment.
  • Working knowledge of ICH/GCP regulations and clinical protocols.
  • Ability to accommodate a flexible work schedule according to clinical trial priorities, as needed.
  • Ability to work independently with minimal direction/oversight and within a team structure.
  • Ability to independently problem-solve or propose innovative solutions.
  • Superior listening and communication skills.
  • Experienced with leading small group meetings and/or managing vendor relationships.
  • Positive and can-do approach.
  • Proficient in the use of Microsoft Office, advanced skills in Excel highly desirable.

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