Clinical Project Assistant

hace 4 días


Buenos Aires, Buenos Aires C.F., Argentina Curebase A tiempo completo

What You'll Do

  1. Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project.
  2. Provide support for site management activities to Clinical Project Manager / Director and CRA.
  3. Maintain clinical project documents in paper and/or electronic Trial Master Files and perform TMF reconciliation and period review follow-up.
  4. Prepare Investigator Site Files.
  5. Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications and plans; distribute reports and communications to sites, vendors, Sponsors, and internal team members.
  6. Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings.
  7. Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management.
  8. Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities.

What You Bring

  1. Bachelor's degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience.
  2. General knowledge of medical and pharmaceutical terminology.
  3. General knowledge of the drug development and clinical trial process.
  4. General knowledge of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
  5. Strong verbal and written communication skills, organizational and record retention skills, customer service and interpersonal skills.
  6. Ability to successfully work within a team-based environment, independently with minimal oversight.
  7. Proven ability to handle multiple tasks and manage time efficiently.
  8. Strong computer literacy and proficient with Microsoft Office Suite.
  9. Ability to quickly learn and adapt to new systems and technologies.

Why CTI?

  1. We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward.
  2. We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department.
  3. We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade.
  4. Our culture is unparalleled - Click here to learn more about "The CTI Way."
  5. We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (Click here to learn more about our "CTI Cares" program).
  6. We are looking toward the future - We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate.
  7. Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market.
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