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Clinical Research Associate II

1 hour, 54 minutes ago
Australia
Full-time
Junior
Project Manager
Project and Program Management
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 63

Description

  • Oversee all aspects of study site management to protect patient safety and maintain data quality.
  • Provide guidance on audit readiness and support audit preparation and follow-up actions.
  • Update, track, and maintain study-specific trial management tools, systems, and status reports.
  • Manage site start-up activities, including feasibility, investigator recruitment, EC/IRB submissions, and regulatory document review when required.
  • Assist with study budget negotiations and investigator contract execution when required.
  • Verify informed consent is properly obtained and documented, and assess site-level risks to subject safety and data integrity.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits in accordance with protocol, local laws, ICH-GCP, and SOPs.
  • Prepare and submit accurate monitoring reports and other required documentation from on-site and remote visits.
  • Review the Investigator Site File and reconcile it with the Trial Master File to ensure completeness and proper archiving.
  • Communicate protocol issues and deviations with site personnel and study teams, and implement corrective actions.
  • Perform investigational product inventory, reconciliation, storage, security, and dispensing reviews.
  • Review EDC data, resolve queries, and support data management in resolving discrepancies.
  • Identify and process serious adverse events according to study procedures.
  • Escalate site risks with recommended contingencies and own timely resolution with minimal support.
  • Participate in investigator meetings, sponsor meetings, and clinical training sessions as required.
  • Travel as necessary based on project needs.

Requirements

  • Bachelor's degree or international equivalent, or an equivalent combination of education and experience, ideally 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 in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Fluency in English, both verbal and written.
  • Working knowledge of the drug development process.
  • Ability to demonstrate flexibility, teamwork, and a customer service demeanor.
  • Strong attention to detail and accuracy.
  • Willingness to travel 60-70%.
  • Solid experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.
  • Good knowledge and use of ICH-GCP, Precision SOPs, and regulatory guidance.

Benefits

  • Opportunity to support groundbreaking oncology and rare disease research.
  • Work in a growing organization where employee contributions are appreciated.
  • Opportunity to have ideas valued and nurtured and to help drive positive change.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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