Sr. Clinical Trial Associate at Aspen Tech Labs in Lexington, Massachusetts

Posted in Other 19 days ago.

Type: Full-Time





Job Description:

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.
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