Study Start-up Specialist II

Join or sign in to find your next job

Join to apply for the Study Start-up Specialist II role at Fortrea

6 days ago Be among the first 25 applicants

Join to apply for the Study Start-up Specialist II role at Fortrea

Get AI-powered advice on this job and more exclusive features.

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 Fortrea 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 Fortrea 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.Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionEducation and Training

Referrals increase your chances of interviewing at Fortrea by 2x

Get notified about new Student jobs in Sydney, New South Wales, Australia.

St Leonards, New South Wales, Australia 1 week ago

Surry Hills, New South Wales, Australia 3 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

STAR (Student Training and Rotation) Program Intern - Sydney

North Sydney, New South Wales, Australia 4 days ago

Sydney, New South Wales, Australia 1 day ago

2025/26 CommBank Summer Intern Program Campaign

Sydney, New South Wales, Australia 4 weeks ago

Project Management/Business Development intern

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 5 days ago

Project Management Intern - AI Data (Eco Operations) - 2025 Start

Sydney, New South Wales, Australia 6 days ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 1 day ago

Expression of Interest - 2027 Sydney Graduate Program

Milperra, New South Wales, Australia 3 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 3 weeks ago

Sydney, New South Wales, Australia 3 weeks ago

Dee Why, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 3 weeks ago

Sydney, New South Wales, Australia 4 days ago

Sydney, New South Wales, Australia 3 weeks ago

Liverpool, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 2 weeks ago

Richmond, New South Wales, Australia 3 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 4 days ago

Expression of Interest - Graduate & Seasonal Clerks

Sydney, New South Wales, Australia 7 months ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

---