Start-Up CRA, Poland
- Contract Type
Study Start-Up Specialist / SSU CRA
Here at Syneos Health we are currently recruiting for a Study Start-Up Specialist or SSU CRA to be based in office in Warsaw and work closely with one of Global Pharmaceutical company.
- Train study site personnel on the protocol and applicable regulatory requirements.
- Facilitate Quality Assurance Audit processes as indicated.
- Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
- Negotiates investigator/ hospital agreements with stakeholders.
- Uses multiple technologies to maintain open and frequent communication with internal & external customers.
The ideal candidate will need the following experience / skills to be considered:
- Proven minimum 2-3 years' experience in clinical research industry, including min. 1 year in independent EC/CA submissions.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Good written and verbal communication skills. Written and verbal fluency in English and Polish.
- Previous experience with electronic data capture systems is desirable.
There are many benefits available to employees. They include competitive compensation and benefits (details on request).
If you have the required experience for this position and are eligible to work in the required location then please apply by CV or contact Magdalena Raczynska on email@example.com
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Please be advised only selected candidates will be contacted back.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
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