Site Activation Specialist

1 week ago

Brisbane, Queensland, Australia Pharmiweb Full time

Critical Role in Site Activation

Parexel FSP is seeking a highly skilled Site Activation Specialist to join our team in Hungary. As a key member of our site activation team, you will be responsible for leading or supporting operational activities from startup to close-out for assigned studies and investigator sites.

Key Responsibilities:

  • Clinical Trial Site Activation:
    • Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
    • Register investigator sites and Client stakeholders in Client registries and systems as required.
    • Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.
  • Clinical Trials Conduct:
    • Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct.
    • Ensure maintenance of IRB/Ethics and other committees' activities as applicable.
    • Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
  • Internal & External Communication:
    • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
    • Attend study Start-up meeting and provide functional updates on a country and site level.
    • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.

Requirements:

  • Minimum 2 years' relevant experience in clinical site management.
  • Experience working in the pharmaceutical industry/or CRO in study site activation.
  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
  • Good technical skills and ability to learn and use multiple systems.

About Parexel FSP:

Parexel FSP is a leading Contract Research Organization (CRO) that transforms scientific discoveries into new treatments. We are committed to delivering high-quality services to our clients and are seeking talented individuals to join our team.

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