CRA II (Croatia)

Home-based 

Permanent contract

Sponsor-dedicated

Here at Syneos Health we are currently recruiting for a CRA II to work for one the world’s leading Pharmaceutical companies.

The position is fully home based in Croatia. 

Job Details:

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.

Eligibility/Qualifications/Requirements

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) and Slovenian as well
• 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 and III competency profile.
• 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.

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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.