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Clinical Research Associate II

2 hours, 7 minutes ago
Australia
Full-time
Junior
Project Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 103

Description

  • Provide overall support to study sites and clinical project teams engaged in clinical research studies.
  • Oversee site management to protect patient safety and maintain high-quality data with low query levels.
  • Support audit readiness and preparation for audits, including follow-up actions.
  • Update, track, and maintain trial management tools, systems, and status reports.
  • Manage site start-up activities such as feasibility, investigator recruitment, EC/IRB submissions, and regulatory document review when required.
  • Assist with study budget negotiations and investigator contract execution when required.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits on-site and remotely.
  • Prepare and submit accurate, timely monitoring reports and required project documentation.
  • Review ISF and TMF records for accuracy, timeliness, completeness, and proper archiving.
  • Communicate protocol issues, deviations, and action items with site personnel and internal study teams.
  • Perform investigational product inventory, reconciliation, storage, security, and labeling/release checks.
  • Review EDC/CRF and patient data, resolve queries, and support data quality activities.
  • Identify and process serious adverse events and escalate site risks with recommended contingencies.
  • Participate in investigator meetings, sponsor meetings, global monitoring meetings, and clinical training sessions.
  • Travel as needed according to project requirements.

Requirements

  • Bachelor's degree, international equivalent, or an equivalent combination of education and experience in a business, scientific, or healthcare discipline.
  • Minimum of 2 years of on-site monitoring experience.
  • 1 year of oncology and phase I experience preferred.
  • High proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Working knowledge of the drug development process.
  • Fluency in English, both verbal and written.
  • Ability to maintain high attention to detail and accuracy over extended periods.
  • Customer service demeanor with flexibility and teamwork.
  • Solid experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.
  • Travel required 60-70%.

Benefits

  • Opportunity to work on groundbreaking cancer therapies in a growing organization.
  • Employees are encouraged to share input and have their ideas valued and nurtured.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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