Clinical Research Coordinator

7 days ago

Canberra, ACT, Australia Pharmiweb Full time

Job Summary: We are seeking a highly skilled Clinical Research Coordinator to join our team at Pharmiweb. As a Clinical Research Coordinator, you will play a critical role in the start-up phase of clinical trials, ensuring the smooth execution of site selection, feasibility assessments, and regulatory submissions.

Key Responsibilities:

  • Feasibility Assessments: Conduct thorough feasibility assessments to evaluate the suitability of sites for clinical trials, collaborating with site investigators and study teams to gather necessary information and assess site capabilities.
  • Site Selection: Identify and recommend potential study sites based on feasibility assessments and strategic alignment with study goals, performing Investigator due diligence checks in accordance with company SOPs.
  • Regulatory Submissions: Prepare and submit regulatory documents required for study start-up, ensuring compliance with all applicable regulations and guidelines.
  • Start-Up Coordination: Coordinate site initiation visits and ensure all required documentation and contracts are in place before study start, working closely with clinical operations, regulatory affairs, and other departments.
  • Documentation and Reporting: Maintain accurate and up-to-date records of all study start-up activities, providing regular updates and reports to management on the status of study start-up activities.
  • Compliance and Quality: Ensure adherence to company SOPs, GCP, and other regulatory requirements, participating in audits and inspections as needed.

Requirements:

  • Education: BA/BS Degree in Business, Life Sciences, or Paralegal
  • Experience: Minimum of 3 years of independent study start-up/feasibility experience in clinical research
  • Skills: Strong understanding of clinical trial processes, regulations, and guidelines, excellent organizational and project management skills, ability to work independently and manage multiple projects simultaneously, strong communication and interpersonal skills, proficiency in MS Office Suite and clinical trial management systems (CTMS)

About Us: Pharmiweb is a leading clinical research organization, powered by healthcare intelligence. We offer a competitive salary, a range of benefits, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.

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