Fortrea, a leading global contract research organization (CRO), is passionate about scientific rigor and has decades of experience in clinical development. With operations in over 100 countries, Fortrea provides a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas to pharmaceutical, biotechnology, and medical device customers. The company is dedicated to transforming drug and device development for partners and patients worldwide, ensuring the swift delivery of life-changing ideas and therapies to those in need.
Responsibilities in the Job
As a Start-up Associate at Fortrea, you will play a crucial role in ensuring the successful startup and maintenance of clinical trials. Key responsibilities include:
- Developing awareness of regulatory legislation, guidance, and practice in assigned countries with support from senior staff.
- Assisting in the compilation, preparation, submission, and approval of regulatory documents to IRB/IEC/Third body/Regulatory Authority.
- Serving as the primary contact for investigative sites, collecting necessary documents, and performing quality reviews.
- Ensuring compliance with ICH/GCP, SOPs, budget, quality, and applicable laws and guidelines.
- Updating study documents, status reports, and tracking systems as applicable.
- Adapting Informed Consent Forms and other patient-facing materials to country-specific requirements.
- Identifying and escalating potential risks to meeting deliverables and supporting contract negotiation processes under supervision.
Qualifications
To be considered for the Start-up Associate position, candidates should meet the following minimum requirements:
- Education: University/College degree (life science preferred) or certification in a related allied health profession.
- Experience: 0-2+ years of experience in a related field, with a demonstrated basic understanding of the clinical trial process and working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
Skills
To excel in this role, candidates should possess:
- Analytical Skills: Ability to evaluate data, draw conclusions, and make informed decisions.
- Communication Skills: Excellent interpersonal and presentation skills, with the ability to communicate complex scientific information effectively.
- Attention to Detail: High level of detail orientation to ensure quality and compliance in all aspects of the role.
- Organizational Skills: Ability to manage multiple tasks, prioritize activities, and meet deadlines in a fast-paced environment.
- Technical Proficiency: Familiarity with computer applications, web-based platforms, and Clinical Trials Information System (CTIS) tasks.
