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Senior In-house CRA (LATAM)

1 hour, 23 minutes ago
Mexico, Argentina, Brazil, Chile, Peru, Colombia
Full-time
Senior
Operations Specialist
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 106

Description

  • Support study sites and clinical project teams throughout clinical research studies.
  • Assist with investigator recruitment, site feasibility, and site selection activities.
  • Schedule internal and external meetings as needed.
  • Prepare and distribute Investigator Site Files and coordinate with shipping vendors when required.
  • Collect, review, maintain, and close out essential documents in the TMF and site files.
  • Set up and maintain site-related data in clinical systems and track milestones in the CTMS.
  • Serve as a site contact for study and site management issues, including questions, supply management, and escalation of risks.
  • Ensure timely and complete site data entry in EDC and other study systems.
  • Send study updates, newsletters, and core documents to site personnel.
  • Support sample logistics, study supply management, local submissions, and IRB/IEC requirements.
  • Review site-level data, resolve queries, and help facilitate database closure and freezing.
  • Support investigator payment processing by following up on trial invoices and keeping CTMS updated.
  • Participate in site visits, on-site activities, remote ISF review, and investigational product accountability when needed.
  • Provide training, mentoring, and lead multiple In-house CRAs on a project.
  • Assist with developing training materials, study-specific documents, procedures, and clinical project documents.

Requirements

  • Bachelor's degree or international equivalent, or an equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
  • 4 years of clinical trial or related experience.
  • High proficiency with Microsoft Office programs, including Outlook, Word, Excel, and PowerPoint.
  • Fluency in English, both written and verbal.
  • In-depth knowledge of the drug development process.
  • Experience using CTMS, TMF, and EDC systems.
  • Ability to travel as needed.
  • Customer service mindset with flexibility and teamwork.
  • Strong attention to detail and accuracy.
  • Preferred: solid experience in clinical research or related work.
  • Preferred: excellent organizational skills.
  • Preferred: ability to work efficiently in a remote environment.
  • Preferred: ability to resolve complex problems using knowledge, precedents, and practices.
  • Preferred: ability to support junior In-House CRAs with issue identification and resolution.

Benefits

  • Remote work environment.
  • Opportunity to help build a new LATAM regional function.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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