CRA Poland Sponsor-dedicated
- Experience Level
- Experienced (non-manager)
CRA II (Poland)
Home-based or office-based
Here at Syneos Health we are currently recruiting for a CRA II for one of our sponsors in Poland with studies within oncology areas.
As CRA II your main duties will include, but will not be limited to:
- Ensure for Country trial start up activities, i.e. Translation of study documents, HA submission and Clinical supplies check-up/import at project level.
- Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
- Support the site initiation and training executed by CRAs.
- Ensure Country Specific master file and facilitate preparation and monitor the collection of site Level documents by CRAs; resolve problems as required.
- Ensure Planning and Set up the local trial timeline with CRA for the key metrics i.e. IRB submission, site contract, site initiation, patient recruitment, routine monitoring, close out activities.
- Monitor on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics.
- Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA if necessary.
- Liaise with global TA/BU clinical teams and CPOs to identify issues and mediate resolution in a timely manner at a project level.
- Review study monitoring reports which monitor generated, as assigned.
- Identify project and Clinical Operations issues that will impact the successful conduct of a trial and bring to the attention of the GMO Head for information and/or resolution in a timely manner.
- Supervise the monitor of the implementation of site closeout activities.
- Act as local and/or global CRA lead and author global monitoring plan, as assigned.
- Act as a mentor to new associates for purposes of field training, as assigned.
- Work to coordinate for audits if necessary.
- Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
The ideal candidate will need the following experience / skills to be considered:
- Education: A degree in scientific or health discipline required and advanced degree is preferable
- Fluent English (both written and spoken)
- Understand and apply medical and business know-ledge to clinical trial execution.
- About 2 years’ experience in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile.
- Oncology experience will be asset.
- Solid understanding of clinical trial design, trial ex-ecution and operations.
- Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
- Expertise in communication, managing multiple priorities and computer literacy.
- Proven people management skills with demonstrated expertise in working on teams.
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
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.
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.