Study Site Specialist

2 weeks ago

Sydney, New South Wales, Australia Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.


Responsibilities:

  • Budget and

Contract Management:
Support country and site budgets. Develop, negotiate, and complete Clinical Trial Research Agreements (CTRA). Oversee and track clinical research-related payments, including payment reconciliation at study close-out.-
Financial Compliance: Oversee FCPA, DPS/OFAC, and maintenance of financial systems

  • Regulatory Submissions:
Contribute to the execution and oversight of clinical trial country submissions and approvals for assigned protocols. Develop working knowledge of local language materials, including local language informed consents and translations.

Interact with IRB/IEC and Regulatory Authority as needed.- Quality and Compliance: Ensure quality and compliance in assigned protocols within the country.

Support country deliverables, timelines, and results to meet commitments.- SOP Development: Contribute to the development of local Standard Operating Procedures (SOPs)

  • Coordination and Liaison:
Coordinate and liaise with clinical operations, finance, and legal teams to ensure country deliverables are met for submissions, budgets, CTRAs, and local milestones

  • Vendor Support:
Provide support to local vendors as applicable

  • Local Process Support:
Manage local processes, clinical and ancillary supplies, importing and exporting requirements, supplies destruction, electronic/hard copy filing, archiving, and retention requirements

  • Regulatory and

Financial Compliance:
Support local regulatory and financial compliance

  • Stakeholder Management:
Acquire knowledge on how to influence investigators, external partners, and country operations, adhering to budget targets and payment timelines

  • Internal Collaboration:
Work in partnership with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, and externally with sites, IRB/IECs, and Regulatory Authorities

  • Continuous Improvement:
Contribute to initiatives and projects that add value to the business.

Act as/support process Subject Matter Expert (SME), sharing best practices and making recommendations for continuous improvement.- Team Contribution: Share best practices and support the knowledge development of the SSU team and other country operations roles.


Qualifications:

  • Bachelor's degree in a relevant field (e.g., life sciences).
  • Experience in clinical research, particularly in budget and contract management.
  • Strong knowledge of regulatory and financial compliance.
  • Excellent organizational and communication skills.
  • Ability to work independently and as part of a team.
  • Detailoriented with strong analytical skills.
Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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