Job Description Clinical Research Associate (CRA) at GOUYA INSIGHTS
Are you an experienced Clinical Research Associate (CRA) looking to further strengthen your expertise in clinical trial execution? Gouya Insights is seeking a motivated and hands‑on CRA to join our growing clinical operations team.
In this role, you will be responsible for on‑site and remote monitoring activities, ensuring protocol adherence, data integrity, and subject safety. You will work closely with investigational sites and internal teams to oversee regulatory documentation, ethics committee and hospital submissions at site level, and trial conduct in accordance with SOPs, ICH‑GCP, and applicable regulatory requirements. All activities are performed with a strong focus on quality, inspection readiness, and timely delivery.
If you enjoy working in a dynamic clinical research environment and want to contribute beyond routine monitoring while maintaining a strong focus on site‑level excellence, you will feel right at home at Gouya Insights.
What you will be responsible for:
* Perform clinical monitoring activities in compliance with ICH‑GCP, study protocols, SOPs, and applicable regulations
* Serve as the primary point of contact for assigned study sites, ensuring effective communication between sites, sponsors, and involved parties
* Manage and track regulatory authority, ethics committee, and hospital submissions, including CTIS follow‑up and approval tracking
* Support clinical project management activities, such as timelines, trackers, coordination, and study oversight
* Collaborate closely with cross‑functional internal and external stakeholders
* Ensure documentation completeness, quality, and inspection readiness
* Proactively identify risks, issues, and opportunities for process and quality improvement
* Support additional cross‑functional activities as required by project needs
What you bring to the table:
* 3+ years of Clinical Research Associate (CRA) experience in clinical monitoring and an advanced degree in Life Sciences, Medical, or Pharmaceutical studies, or an equivalent combination of education and experience
* Proven experience with regulatory authority, ethics committee, and hospital submissions
* Willingness and motivation to expand into clinical project manager responsibilities
* Excellent command of English (written and spoken) and working proficiency in German (B2 level or higher)
* Good teamwork skills
* Problem‑solving skills
* Results and detail‑oriented approach to work delivery and output
* Ability to prioritize own workloads to meet deadlines
* Strong software and computer skills, including MS Office applications
* Ability to establish and maintain effective working relationships with co‑workers, managers, and clients
* Ability to manage and prioritize tasks independently
* Availability for full‑time employment (flexible working models possible, e.g. 32–40 hours/week)
* Willingness to occasionally work off‑site and travel (domestic and international)
* Vision: Contribute to clinical research projects that bring value to sponsors and improve patients’ lives
* Ambition: Be part of a highly motivated and growing clinical development company
* Culture: A collaborative, supportive, and international team environment
* Work environment: Hybrid and flexible working setup with autonomy and trust
* Compensation: Competitive salary package and benefits
* Personal growth: to develop toward a Clinical Project Manager profile through cross‑functional learning
A Bit About Us…
Gouya Insights is a clinical development consulting and services company supporting biotech, pharmaceutical, and medical device sponsors worldwide. We provide end‑to‑end support across the clinical development lifecycle, acting as an interface between sponsors, clinical operations, and regulatory stakeholders to ensure high‑quality and inspection‑ready clinical trials.
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