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Study Start-up Specialist II

2 weeks ago

Sydney, Australia Fortrea Full time US$90,000 - US$120,000 per year

Are you looking for a stable position with a well-established company, a place where you could feel comfortable? Do you like working with people who are friendly and reliable? Join us as we speed up the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, building new possibilities for our clients.

In this role you will:

  • Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance

  • Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines

  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.

  • Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.

  • Participate in team meetings to progress trials and identify site issues that might impact the timelines.

  • When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.

  • Liaise with Covance Regulatory department regarding document submission requirements, if applicable.

  • Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.

  • May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate

  • Undertake tasks delegated by senior team members, depending upon country and situational requirements.

  • Perform other duties as assigned by management.

Required Experience:

  • Intermediate /Advanced experience in clinical development or clinical trial start up/ regulatory process.

  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites

  • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

This role is for upcoming future opportunities that may arise at Fortrea

Learn more about our EEO & Accommodations request here.