Senior CTA (Regulatory) – Sponsor Dedicated

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. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are recruiting for our sponsor-dedicated (FSP) business in Türkiye and are seeking to hire a Senior CTA (Regulatory) on a permanent, full-time contract.

This hybrid position is offered in Istanbul and Ankara.

Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.

Summary of Responsibilities:

• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions
• Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
• Ensure collection and distribution of study tools and documents
• Update clinical trial databases (CTMS) and tracker
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Assist with eTMF reconciliation
• Prepare Investigator trial file binders
• Execute eTMF Quality Control Plan
• Provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions
• Obtain, track and update study insurance certificates
• Publish study results for GCTO and RA where required per local legislation

Qualifications (Minimum Required):

• University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
• Understanding of ICH-GCP guidelines.
• Understanding of the clinical trial process.

Experience (Minimum Required):

• A minimum of 2 years of industry experience in a related role (e.g., IHCRA, CTA, study coordinator).
• Previous experience as a CTA.
• Experience in interventional studies.
• Experience in EC/RA submissions preferred.
• Good planning, organization, time management and problem-solving skills.
• Good communication skills, oral and written.
• Works efficiently and effectively in a matrix environment.

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Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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 Privacy Statement. 

If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.

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