Reporting to the Clinical Project Manager/Director, Clinical Operations, the Clinical Trial Associate (CTA) / Senior Clinical Trial Associate (Sr CTA) will be tasked to independently provide clinical trial coordination support, along with implementation of clinical operational plans in accordance with regulatory guidelines and ICH/GCP standards. The CTA / Sr CTA will be responsible for providing Clinical Operations support related to study-specific activities and site and vendor management. The CTA / Sr. CTA role may support multiple clinical studies simultaneously.

Responsibilities (including, but not limited to) :

• Manage and serve as a point of contact for study-related vendors and contracted CROs and study team; identifying potential risks and proactively resolving issues with CROs and other vendors; establishing vendor management plans and reviewing quality metrics
• Review monitoring reports, protocol deviations and data listings for studies
• Coordinate cross-functional project-related activities (e.g., protocol deviation review meetings)
• Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning
• Lead the development of reports for communicating study progress and key metrics to Senior Management and program team
• Perform initial review of invoices against contracted services
• Assist with budget management
• Prepare study timelines
• Develop and manage study trackers and provide metrics as needed
• Oversee site monitoring visits for clinical trials as needed
• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections
• Prepare and maintain assigned program files
• Ensure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocols
• Organize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guidelines

QUALIFICATIONS:

• Requires a Bachelor’s degree with at least 2 years of relevant work experience in a pharmaceutical, academic or CRO environment
• Working knowledge of ICH/GCP regulations
• Working knowledge of clinical protocols
• Ability to accommodate a flexible work schedule according to clinical trial(s) 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
• Proficient in the use of Microsoft Office, advanced skills in Excel highly desirable
• Ability to work hybrid schedule (Monday-Thursday in office, Friday remote) in Lexington, MA office
  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

• Manage and serve as a point of contact for study-related vendors and contracted CROs and study team; identifying potential risks and proactively resolving issues with CROs and other vendors; establishing vendor management plans and reviewing quality metrics
• Review monitoring reports, protocol deviations and data listings for studies
• Coordinate cross-functional project-related activities (e.g., protocol deviation review meetings)
• Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning
• Lead the development of reports for communicating study progress and key metrics to Senior Management and program team
• Perform initial review of invoices against contracted services
• Assist with budget management
• Prepare study timelines
• Develop and manage study trackers and provide metrics as needed
• Oversee site monitoring visits for clinical trials as needed
• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections
• Prepare and maintain assigned program files
• Ensure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocols
• Organize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guideline