Clinical Operations Specialist
hace 4 días
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. With a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas, we are transforming drug and device development for partners and patients globally.
About the RoleThis exciting opportunity is for an upcoming future role at Fortrea. As a Clinical Operations Specialist - Regulatory Compliance, you will be accountable for the execution and oversight of local operational clinical trial activities. You will have ownership, oversight, and impact on local regulatory and financial compliance at a country operations level.
Your responsibilities will include adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws, and procedures with minimal support from client management. You will require skilled knowledge of budget and contract negotiations, the local ethics, legislation, and regulatory environment, submission and approval processes, development of local Informed Consent, as well as other site-ready and ongoing study deliverables.
You will also be responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments. Additionally, you will contribute to the development of local SOPs, work in close collaboration internally with Clinical country operations, Country Quality Manager, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal, and regional operations, and externally with vendors and sites, IRB/IECs, and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
What We're Looking For
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology;
- Relevant and equivalent experience in lieu of educational requirements;
- A minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a healthcare setting;
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries;
- Fluent in local office language and in English, both written and verbal;
- Excellent communication skills, oral and written;
- Self-motivation with the ability to work under pressure to meet deadlines;
- Works well independently and in a team environment;
- Detail and process-oriented;
- Positive attitude and approach;
- Interact with internal and external customers with a high degree of professionalism and discretion;
Salary: $85,000 - $115,000 per year based on experience.
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