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Clinical Trial Associate (CTA) - Lexington, MA

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Active since 27-10-2017 Job category Pharmacy
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization:

The Clinical Trial Associate (CTA) is a member of the Clinical Operations Department. The Clinical Operations department is responsible for the management (planning, implementation, maintenance and close out) of the Clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety. There are approximately 10 employees in the department with some of the activities outsourced to Clinical Research Organizations.

The CTA supports the project team in all aspects of the execution of the clinical trial.

Key result areas (major duties, accountabilities and responsibilities):

The Clinical Trial Associate is a key member of the clinical trial team, and supports the execution of the clinical trial. This is a growth position that will require flexibility towards daily work, and an interest in learning new activities. The candidate should be ready to be challenged and will be exposed to all aspects of clinical trial execution.

Clinical Trial Execution

  • Support the management of the Trial Master File (TMF), i.e. set up and maintenance in line with ICH/GCP. The CTA will own delivery of an accurate and complete TMF for the entirety of the trial, and will own oversight of the CRAs and sites for this task.
  • Support the CTM with study finance processes (invoice processing, approval and tracking and accruals).
  • Collect and collate the data from the different departments needed in the management reports.
  • Deliver routine reports, review for accuracy and potential escalation items.
  • Plan and coordinate logistics of project meetings in an efficient way (including room bookings, prepare and start up conference calls, videoconferences and web based presentations (WebEx), lunches and meeting minutes, as appropriate).
  • Support in the preparation of Ethics Committee submission packages within set timelines.
  • Arrange translations of study related documents by third parties.
  • Arrange project related courier packages.
  • Support routine shipment arrangements from sites to central labs.

Qualifications & Skills:

  • Bachelor’s degree preferred; medical related degree preferred
  • Qualification in a relevant/related discipline
  • 2 years of relevant work experience preferred
  • Computer skills: basic to intermediate level (active knowledge of MS Office applications)
  • Basic knowledge of current ICH-GCP regulations
  • Fluent in written and verbal English

Core competencies:

  • Enthusiastic and proactive
  • Able to work under stressful situations.
  • Flexible
  • Dedicated to growth; ready to be challenged.
  • Accurate, with attention to detail
  • Team player, motivated to support the team
  • Awareness of the sensitive and confidential nature of information and/ or situations.
  • Has developed and established skills to perform a variety of day-to-day activities.
  • Recognizes and solves typical problems that can occur in own work area, without supervisory approval.
  • Typically finds solutions in existing procedures and precedents.
More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Biotechnology
Region United States
Keywords Clinical Trial

Contact information

Name Jennifer Wagner

Location

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