In-house CRA II

3 hours, 22 minutes ago
Full-time
Junior
Project and Program Management
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

Description

  • Support study sites and clinical project teams across multiple clinical research studies.
  • Assist with investigator recruitment and site feasibility activities using questionnaires, scripts, and study materials.
  • Schedule internal and external meetings and coordinate site-related communications.
  • Prepare and distribute Investigator Site Files and coordinate shipping support when needed.
  • Collect, review, maintain, and close out essential documents in the trial master file (TMF).
  • Maintain site data and study milestones in CTMS and other clinical systems.
  • Serve as a point of contact for study sites and help resolve site management issues.
  • Support timely site data entry in EDC and other required systems.
  • Send study updates, newsletters, and core documents to site personnel.
  • Assist with site tracking, invoice follow-up, investigator payments, and study closeout activities.
  • Support remote and on-site visits, central monitoring activities, and Independent Essential Document review when needed.
  • Assist with investigational product accountability, sample tracking, and local submission requirements.

Requirements

  • Bachelor's degree or international equivalent, or equivalent education and experience, ideally in a business, scientific, or healthcare discipline.
  • Minimum of 2 years of relevant experience.
  • High proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Fluency in Serbian and English, both written and verbal.
  • Working knowledge of the drug development process.
  • Ability to travel as needed.
  • Solid experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.
  • Strong knowledge and use of ICH-GCP, Precision SOPs, and regulatory guidance.
  • Strong interpersonal skills and ability to work independently and in a team environment.
  • Detail-oriented with high attention to accuracy and the ability to focus for extended periods.

Benefits

  • Remote work environment.
  • Opportunity to work for a global clinical research organization.
  • 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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