Reporting to the Associate Director, Clinical Operations, the Senior Clinical Trial Associate (Sr CTA) will be responsible for the daily administrative parts of clinical trials, at all stages of the process along with implementation of clinical operational plans, study specific reports and vendor management activities in accordance with regulatory guidelines and ICH/GCP standards.
This role will be based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Manage study-related vendors and serving as a point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; 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., Clinical Data 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 and provide input to study timelines
Develop and manage study trackers and provide metrics as needed
Perform and/or oversee site monitoring visits for clinical trials as needed
Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections
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 3 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
Positive and "can do" approach
Proficient in the use of Microsoft Office, advanced skills in Excel highly desirable
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.